Bausch & Lomb Incorporated
FDA Approved Drugs

Bausch & Lomb Incorporated

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

Discontinued OTC RX Unclassified
  • Total Records 114
  • Latest Approval Date Aug 18, 2021
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
114
View
Unclassified
2
View
Discontinued
87
View
OTC
4
View
RX
21
View
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Company

Bausch & Lomb Incorporated

Country

Canada

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Company Snapshot

Bausch & Lomb Incorporated

520 Applewood Crescent, Vaughan, Ontario, Canada L4K 4B4

Canada

www.bausch.com/ View on Map
FDA Approved Drug Records ( 114 records )
1994
25 Feb
Discontinued Application: 40063

Drug Name

ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE

Product Number

1

Dosage Form

-

Strength

2%;0.79%

Approval Date

1994-02-25

40063 / 1

Active Ingredient

ACETIC ACID, GLACIAL; ALUMINUM ACETATE

Application Number

40063

Product Number

1

Dosage Form

-

Strength

2%;0.79%

Approval Date

1994-02-25

Regulatory Status

Discontinued

2006
01 Dec
OTC Application: 21996

Drug Name

ALAWAY

Product Number

1

Dosage Form

-

Strength

EQ 0.025% BASE

Approval Date

2006-12-01

21996 / 1

Active Ingredient

KETOTIFEN FUMARATE

Application Number

21996

Product Number

1

Dosage Form

-

Strength

EQ 0.025% BASE

Approval Date

2006-12-01

Regulatory Status

OTC

1998
09 Mar
RX Application: 20803

Drug Name

ALREX

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1998-03-09

20803 / 1

Active Ingredient

LOTEPREDNOL ETABONATE

Application Number

20803

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1998-03-09

Regulatory Status

RX

1984
28 Mar
Discontinued Application: 62453

Drug Name

BACITRACIN

Product Number

1

Dosage Form

-

Strength

500 UNITS/GM

Approval Date

1984-03-28

62453 / 1

Active Ingredient

BACITRACIN

Application Number

62453

Product Number

1

Dosage Form

-

Strength

500 UNITS/GM

Approval Date

1984-03-28

Regulatory Status

Discontinued

1982
09 Sep
Discontinued Application: 62386

Drug Name

BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE

Product Number

1

Dosage Form

-

Strength

400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

1982-09-09

62386 / 1

Active Ingredient

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62386

Product Number

1

Dosage Form

-

Strength

400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

1982-09-09

Regulatory Status

Discontinued

2009
28 May
RX Application: 22308

Drug Name

BESIVANCE

Product Number

1

Dosage Form

-

Strength

EQ 0.6% BASE

Approval Date

2009-05-28

22308 / 1

Active Ingredient

BESIFLOXACIN HYDROCHLORIDE

Application Number

22308

Product Number

1

Dosage Form

-

Strength

EQ 0.6% BASE

Approval Date

2009-05-28

Regulatory Status

RX

1987
29 May
Discontinued Application: 70484

Drug Name

BETAMETHASONE VALERATE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1987-05-29

70484 / 1

Active Ingredient

BETAMETHASONE VALERATE

Application Number

70484

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1987-05-29

Regulatory Status

Discontinued

1987
29 May
Discontinued Application: 70485

Drug Name

BETAMETHASONE VALERATE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1987-05-29

70485 / 1

Active Ingredient

BETAMETHASONE VALERATE

Application Number

70485

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1987-05-29

Regulatory Status

Discontinued

1987
29 May
Discontinued Application: 70486

Drug Name

BETAMETHASONE VALERATE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1987-05-29

70486 / 1

Active Ingredient

BETAMETHASONE VALERATE

Application Number

70486

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1987-05-29

Regulatory Status

Discontinued

1985
21 Aug
Discontinued Application: 88606

Drug Name

BOROFAIR

Product Number

1

Dosage Form

-

Strength

2%;0.79%

Approval Date

1985-08-21

88606 / 1

Active Ingredient

ACETIC ACID, GLACIAL; ALUMINUM ACETATE

Application Number

88606

Product Number

1

Dosage Form

-

Strength

2%;0.79%

Approval Date

1985-08-21

Regulatory Status

Discontinued

2021
18 Aug
RX Application: 204884

Drug Name

BRINZOLAMIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2021-08-18

204884 / 1

Active Ingredient

BRINZOLAMIDE

Application Number

204884

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2021-08-18

Regulatory Status

RX

1986
21 May
Discontinued Application: 70292

Drug Name

CARBACHOL

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1986-05-21

70292 / 1

Active Ingredient

CARBACHOL

Application Number

70292

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1986-05-21

Regulatory Status

Discontinued

2000
20 Jan
Discontinued Application: 75546

Drug Name

CARTEOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2000-01-20

75546 / 1

Active Ingredient

CARTEOLOL HYDROCHLORIDE

Application Number

75546

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2000-01-20

Regulatory Status

Discontinued

2015
11 Feb
OTC Application: 21996

Drug Name

CHILDRENS ALAWAY

Product Number

2

Dosage Form

-

Strength

EQ 0.025% BASE

Approval Date

2015-02-11

21996 / 2

Active Ingredient

KETOTIFEN FUMARATE

Application Number

21996

Product Number

2

Dosage Form

-

Strength

EQ 0.025% BASE

Approval Date

2015-02-11

Regulatory Status

OTC

1983
14 Apr
Discontinued Application: 62437

Drug Name

CHLOROFAIR

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1983-04-14

62437 / 1

Active Ingredient

CHLORAMPHENICOL

Application Number

62437

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1983-04-14

Regulatory Status

Discontinued

1983
21 Apr
Discontinued Application: 62439

Drug Name

CHLOROFAIR

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1983-04-21

62439 / 1

Active Ingredient

CHLORAMPHENICOL

Application Number

62439

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1983-04-21

Regulatory Status

Discontinued

1995
30 Jan
Discontinued Application: 74443

Drug Name

CROLOM

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1995-01-30

74443 / 1

Active Ingredient

CROMOLYN SODIUM

Application Number

74443

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1995-01-30

Regulatory Status

Discontinued

2001
03 Jul
OTC Application: 75702

Drug Name

CROMOLYN SODIUM

Product Number

1

Dosage Form

-

Strength

5.2MG/SPRAY

Approval Date

2001-07-03

75702 / 1

Active Ingredient

CROMOLYN SODIUM

Application Number

75702

Product Number

1

Dosage Form

-

Strength

5.2MG/SPRAY

Approval Date

2001-07-03

Regulatory Status

OTC

1982
28 Dec
Discontinued Application: 88071

Drug Name

DEXAIR

Product Number

1

Dosage Form

-

Strength

EQ 0.05% PHOSPHATE

Approval Date

1982-12-28

88071 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Application Number

88071

Product Number

1

Dosage Form

-

Strength

EQ 0.05% PHOSPHATE

Approval Date

1982-12-28

Regulatory Status

Discontinued

1983
15 Dec
Discontinued Application: 88433

Drug Name

DEXAIR

Product Number

1

Dosage Form

-

Strength

EQ 0.1% PHOSPHATE

Approval Date

1983-12-15

88433 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Application Number

88433

Product Number

1

Dosage Form

-

Strength

EQ 0.1% PHOSPHATE

Approval Date

1983-12-15

Regulatory Status

Discontinued

1983
16 May
Discontinued Application: 62411

Drug Name

DEXASPORIN

Product Number

1

Dosage Form

-

Strength

0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

1983-05-16

62411 / 1

Active Ingredient

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62411

Product Number

1

Dosage Form

-

Strength

0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

1983-05-16

Regulatory Status

Discontinued

1983
18 May
Discontinued Application: 62428

Drug Name

DEXASPORIN

Product Number

1

Dosage Form

-

Strength

0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1983-05-18

62428 / 1

Active Ingredient

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62428

Product Number

1

Dosage Form

-

Strength

0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1983-05-18

Regulatory Status

Discontinued

2007
28 Dec
RX Application: 78792

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2007-12-28

78792 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

78792

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2007-12-28

Regulatory Status

RX

1995
19 May
Discontinued Application: 74188

Drug Name

DIPIVEFRIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1995-05-19

74188 / 1

Active Ingredient

DIPIVEFRIN HYDROCHLORIDE

Application Number

74188

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1995-05-19

Regulatory Status

Discontinued

2009
25 Jun
RX Application: 90143

Drug Name

DORZOLAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2009-06-25

90143 / 1

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE

Application Number

90143

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2009-06-25

Regulatory Status

RX

2009
14 Jul
RX Application: 90037

Drug Name

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2009-07-14

90037 / 1

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Application Number

90037

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2009-07-14

Regulatory Status

RX

1984
05 Apr
Discontinued Application: 62481

Drug Name

ERYTHROMYCIN

Product Number

1

Dosage Form

-

Strength

5MG/GM

Approval Date

1984-04-05

62481 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

62481

Product Number

1

Dosage Form

-

Strength

5MG/GM

Approval Date

1984-04-05

Regulatory Status

Discontinued

1984
11 Jul
Discontinued Application: 62485

Drug Name

ERYTHROMYCIN

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

1984-07-11

62485 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

62485

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

1984-07-11

Regulatory Status

Discontinued

1985
25 Jul
Discontinued Application: 62616

Drug Name

ERYTHROMYCIN

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1985-07-25

62616 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

62616

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1985-07-25

Regulatory Status

Discontinued

1985
15 Mar
Discontinued Application: 62558

Drug Name

ERYTHROMYCIN ETHYLSUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE/5ML

Approval Date

1985-03-15

62558 / 1

Active Ingredient

ERYTHROMYCIN ETHYLSUCCINATE

Application Number

62558

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE/5ML

Approval Date

1985-03-15

Regulatory Status

Discontinued

1985
15 Mar
Discontinued Application: 62559

Drug Name

ERYTHROMYCIN ETHYLSUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

1985-03-15

62559 / 1

Active Ingredient

ERYTHROMYCIN ETHYLSUCCINATE

Application Number

62559

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

1985-03-15

Regulatory Status

Discontinued

1993
20 Dec
Discontinued Application: 40059

Drug Name

FLUOCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1993-12-20

40059 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

40059

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1993-12-20

Regulatory Status

Discontinued

1984
08 Feb
Discontinued Application: 88449

Drug Name

FLUOCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1984-02-08

88449 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

88449

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1984-02-08

Regulatory Status

Discontinued

1984
02 Aug
Discontinued Application: 88499

Drug Name

FLUOCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1984-08-02

88499 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

88499

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1984-08-02

Regulatory Status

Discontinued

1984
02 Aug
Discontinued Application: 88506

Drug Name

FLUOCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1984-08-02

88506 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

88506

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1984-08-02

Regulatory Status

Discontinued

1984
27 Feb
Discontinued Application: 88507

Drug Name

FLUOCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1984-02-27

88507 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

88507

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1984-02-27

Regulatory Status

Discontinued

1995
04 Jan
RX Application: 74447

Drug Name

FLURBIPROFEN SODIUM

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

1995-01-04

74447 / 1

Active Ingredient

FLURBIPROFEN SODIUM

Application Number

74447

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

1995-01-04

Regulatory Status

RX

1983
03 May
Discontinued Application: 62440

Drug Name

GENTAFAIR

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1983-05-03

62440 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62440

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1983-05-03

Regulatory Status

Discontinued

1983
26 May
Discontinued Application: 62443

Drug Name

GENTAFAIR

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE/GM

Approval Date

1983-05-26

62443 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62443

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE/GM

Approval Date

1983-05-26

Regulatory Status

Discontinued

1983
26 May
Discontinued Application: 62444

Drug Name

GENTAFAIR

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1983-05-26

62444 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62444

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1983-05-26

Regulatory Status

Discontinued

1983
01 Sep
Discontinued Application: 62458

Drug Name

GENTAFAIR

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1983-09-01

62458 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62458

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1983-09-01

Regulatory Status

Discontinued

1985
28 Aug
Discontinued Application: 62493

Drug Name

GENTAFAIR

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1985-08-28

62493 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62493

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1985-08-28

Regulatory Status

Discontinued

1982
28 Jul
Discontinued Application: 87838

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-07-28

87838 / 1

Active Ingredient

HYDROCORTISONE

Application Number

87838

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-07-28

Regulatory Status

Discontinued

1994
31 Oct
Discontinued Application: 40097

Drug Name

HYDROCORTISONE AND ACETIC ACID

Product Number

1

Dosage Form

-

Strength

2%;1%

Approval Date

1994-10-31

40097 / 1

Active Ingredient

ACETIC ACID, GLACIAL; HYDROCORTISONE

Application Number

40097

Product Number

1

Dosage Form

-

Strength

2%;1%

Approval Date

1994-10-31

Regulatory Status

Discontinued

1986
14 Feb
Discontinued Application: 88862

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1986-02-14

88862 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

88862

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1986-02-14

Regulatory Status

Discontinued

1986
14 Feb
Discontinued Application: 88881

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1986-02-14

88881 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

88881

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1986-02-14

Regulatory Status

Discontinued

1986
14 Feb
Discontinued Application: 89106

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1986-02-14

89106 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

89106

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1986-02-14

Regulatory Status

Discontinued

1986
14 Feb
Discontinued Application: 89107

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1986-02-14

89107 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

89107

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1986-02-14

Regulatory Status

Discontinued

2004
04 Jun
RX Application: 21516

Drug Name

ISTALOL

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2004-06-04

21516 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

21516

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2004-06-04

Regulatory Status

RX

1983
07 Jun
Discontinued Application: 88087

Drug Name

KAINAIR

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1983-06-07

88087 / 1

Active Ingredient

PROPARACAINE HYDROCHLORIDE

Application Number

88087

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1983-06-07

Regulatory Status

Discontinued

1987
07 May
Discontinued Application: 62668

Drug Name

KANAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE/2ML

Approval Date

1987-05-07

62668 / 1

Active Ingredient

KANAMYCIN SULFATE

Application Number

62668

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE/2ML

Approval Date

1987-05-07

Regulatory Status

Discontinued

1987
07 May
Discontinued Application: 62669

Drug Name

KANAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/3ML

Approval Date

1987-05-07

62669 / 1

Active Ingredient

KANAMYCIN SULFATE

Application Number

62669

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/3ML

Approval Date

1987-05-07

Regulatory Status

Discontinued

1987
07 May
Discontinued Application: 62672

Drug Name

KANAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/2ML

Approval Date

1987-05-07

62672 / 1

Active Ingredient

KANAMYCIN SULFATE

Application Number

62672

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/2ML

Approval Date

1987-05-07

Regulatory Status

Discontinued

2011
22 Mar
RX Application: 201006

Drug Name

LATANOPROST

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2011-03-22

201006 / 1

Active Ingredient

LATANOPROST

Application Number

201006

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2011-03-22

Regulatory Status

RX

1994
04 Mar
Discontinued Application: 74307

Drug Name

LEVOBUNOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1994-03-04

74307 / 1

Active Ingredient

LEVOBUNOLOL HYDROCHLORIDE

Application Number

74307

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1994-03-04

Regulatory Status

Discontinued

1998
09 Mar
RX Application: 20583

Drug Name

LOTEMAX

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1998-03-09

20583 / 1

Active Ingredient

LOTEPREDNOL ETABONATE

Application Number

20583

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1998-03-09

Regulatory Status

RX

2011
15 Apr
RX Application: 200738

Drug Name

LOTEMAX

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2011-04-15

200738 / 1

Active Ingredient

LOTEPREDNOL ETABONATE

Application Number

200738

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2011-04-15

Regulatory Status

RX

1996
09 Apr
Discontinued Application: 74643

Drug Name

MINOXIDIL (FOR MEN)

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1996-04-09

74643 / 1

Active Ingredient

MINOXIDIL

Application Number

74643

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1996-04-09

Regulatory Status

Discontinued

1993
22 Sep
RX Application: 20213

Drug Name

MIOCHOL-E

Product Number

1

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1993-09-22

20213 / 1

Active Ingredient

ACETYLCHOLINE CHLORIDE

Application Number

20213

Product Number

1

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1993-09-22

Regulatory Status

RX

1983
16 Sep
Discontinued Application: 88230

Drug Name

MYDRIAFAIR

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1983-09-16

88230 / 1

Active Ingredient

TROPICAMIDE

Application Number

88230

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1983-09-16

Regulatory Status

Discontinued

1983
16 Sep
Discontinued Application: 88274

Drug Name

MYDRIAFAIR

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1983-09-16

88274 / 1

Active Ingredient

TROPICAMIDE

Application Number

88274

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1983-09-16

Regulatory Status

Discontinued

1994
25 May
Discontinued Application: 40073

Drug Name

NAFAZAIR

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1994-05-25

40073 / 1

Active Ingredient

NAPHAZOLINE HYDROCHLORIDE

Application Number

40073

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1994-05-25

Regulatory Status

Discontinued

1983
15 Apr
Discontinued Application: 88101

Drug Name

NAFAZAIR

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1983-04-15

88101 / 1

Active Ingredient

NAPHAZOLINE HYDROCHLORIDE

Application Number

88101

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1983-04-15

Regulatory Status

Discontinued

1985
06 Sep
Discontinued Application: 62381

Drug Name

NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM

Approval Date

1985-09-06

62381 / 1

Active Ingredient

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62381

Product Number

1

Dosage Form

-

Strength

400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM

Approval Date

1985-09-06

Regulatory Status

Discontinued

1995
30 Oct
Discontinued Application: 64055

Drug Name

NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML

Approval Date

1995-10-30

64055 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE

Application Number

64055

Product Number

1

Dosage Form

-

Strength

EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML

Approval Date

1995-10-30

Regulatory Status

Discontinued

1982
31 Aug
Discontinued Application: 62383

Drug Name

NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN

Product Number

1

Dosage Form

-

Strength

0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML

Approval Date

1982-08-31

62383 / 1

Active Ingredient

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62383

Product Number

1

Dosage Form

-

Strength

0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML

Approval Date

1982-08-31

Regulatory Status

Discontinued

1985
18 Sep
Discontinued Application: 62617

Drug Name

NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1985-09-18

62617 / 1

Active Ingredient

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62617

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1985-09-18

Regulatory Status

Discontinued

1985
10 Jan
Discontinued Application: 62539

Drug Name

NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML

Approval Date

1985-01-10

62539 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE

Application Number

62539

Product Number

1

Dosage Form

-

Strength

EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML

Approval Date

1985-01-10

Regulatory Status

Discontinued

1982
29 Sep
Discontinued Application: 62394

Drug Name

NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1982-09-29

62394 / 1

Active Ingredient

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62394

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1982-09-29

Regulatory Status

Discontinued

1985
24 Sep
Discontinued Application: 62623

Drug Name

NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1985-09-24

62623 / 1

Active Ingredient

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62623

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1985-09-24

Regulatory Status

Discontinued

1985
16 Jan
Discontinued Application: 62541

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/ML

Approval Date

1985-01-16

62541 / 1

Active Ingredient

NYSTATIN

Application Number

62541

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/ML

Approval Date

1985-01-16

Regulatory Status

Discontinued

1986
30 Jul
Discontinued Application: 62656

Drug Name

NYSTATIN AND TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

1986-07-30

62656 / 1

Active Ingredient

NYSTATIN; TRIAMCINOLONE ACETONIDE

Application Number

62656

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

1986-07-30

Regulatory Status

Discontinued

1986
30 Jul
Discontinued Application: 62657

Drug Name

NYSTATIN AND TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

1986-07-30

62657 / 1

Active Ingredient

NYSTATIN; TRIAMCINOLONE ACETONIDE

Application Number

62657

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

1986-07-30

Regulatory Status

Discontinued

1983
08 Apr
Discontinued Application: 62430

Drug Name

OCUMYCIN

Product Number

1

Dosage Form

-

Strength

500 UNITS/GM;10,000 UNITS/GM

Approval Date

1983-04-08

62430 / 1

Active Ingredient

BACITRACIN ZINC; POLYMYXIN B SULFATE

Application Number

62430

Product Number

1

Dosage Form

-

Strength

500 UNITS/GM;10,000 UNITS/GM

Approval Date

1983-04-08

Regulatory Status

Discontinued

2004
14 May
RX Application: 76622

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2004-05-14

76622 / 1

Active Ingredient

OFLOXACIN

Application Number

76622

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2004-05-14

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 87506

Drug Name

OPCON

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

87506 / 1

Active Ingredient

NAPHAZOLINE HYDROCHLORIDE

Application Number

87506

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1994
08 Jun
OTC Application: 20065

Drug Name

OPCON-A

Product Number

1

Dosage Form

-

Strength

0.02675%;0.315%

Approval Date

1994-06-08

20065 / 1

Active Ingredient

NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE

Application Number

20065

Product Number

1

Dosage Form

-

Strength

0.02675%;0.315%

Approval Date

1994-06-08

Regulatory Status

OTC

1989
29 Dec
Discontinued Application: 19907

Drug Name

OPTIPRANOLOL

Product Number

1

Dosage Form

-

Strength

0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-12-29

19907 / 1

Active Ingredient

METIPRANOLOL HYDROCHLORIDE

Application Number

19907

Product Number

1

Dosage Form

-

Strength

0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-12-29

Regulatory Status

Discontinued

1982
18 Nov
Discontinued Application: 62399

Drug Name

OTICAIR

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1982-11-18

62399 / 1

Active Ingredient

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62399

Product Number

1

Dosage Form

-

Strength

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

Approval Date

1982-11-18

Regulatory Status

Discontinued

1983
25 Feb
Discontinued Application: 88150

Drug Name

PENTOLAIR

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1983-02-25

88150 / 1

Active Ingredient

CYCLOPENTOLATE HYDROCHLORIDE

Application Number

88150

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1983-02-25

Regulatory Status

Discontinued

1987
09 Feb
Discontinued Application: 88643

Drug Name

PENTOLAIR

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1987-02-09

88643 / 1

Active Ingredient

CYCLOPENTOLATE HYDROCHLORIDE

Application Number

88643

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1987-02-09

Regulatory Status

Discontinued

1984
29 Feb
Discontinued Application: 88415

Drug Name

PREDAIR

Product Number

1

Dosage Form

-

Strength

EQ 0.11% PHOSPHATE

Approval Date

1984-02-29

88415 / 1

Active Ingredient

PREDNISOLONE SODIUM PHOSPHATE

Application Number

88415

Product Number

1

Dosage Form

-

Strength

EQ 0.11% PHOSPHATE

Approval Date

1984-02-29

Regulatory Status

Discontinued

1983
28 Mar
Discontinued Application: 88165

Drug Name

PREDAIR FORTE

Product Number

1

Dosage Form

-

Strength

EQ 0.9% PHOSPHATE

Approval Date

1983-03-28

88165 / 1

Active Ingredient

PREDNISOLONE SODIUM PHOSPHATE

Application Number

88165

Product Number

1

Dosage Form

-

Strength

EQ 0.9% PHOSPHATE

Approval Date

1983-03-28

Regulatory Status

Discontinued

1994
29 Jul
Discontinued Application: 40065

Drug Name

PREDNISOLONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 0.11% PHOSPHATE

Approval Date

1994-07-29

40065 / 1

Active Ingredient

PREDNISOLONE SODIUM PHOSPHATE

Application Number

40065

Product Number

1

Dosage Form

-

Strength

EQ 0.11% PHOSPHATE

Approval Date

1994-07-29

Regulatory Status

Discontinued

1983
19 Apr
Discontinued Application: 88007

Drug Name

PREDSULFAIR

Product Number

1

Dosage Form

-

Strength

0.5%;10%

Approval Date

1983-04-19

88007 / 1

Active Ingredient

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Application Number

88007

Product Number

1

Dosage Form

-

Strength

0.5%;10%

Approval Date

1983-04-19

Regulatory Status

Discontinued

1983
15 Apr
Discontinued Application: 88032

Drug Name

PREDSULFAIR

Product Number

1

Dosage Form

-

Strength

0.5%;10%

Approval Date

1983-04-15

88032 / 1

Active Ingredient

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Application Number

88032

Product Number

1

Dosage Form

-

Strength

0.5%;10%

Approval Date

1983-04-15

Regulatory Status

Discontinued

1985
24 Dec
Discontinued Application: 88837

Drug Name

PREDSULFAIR II

Product Number

1

Dosage Form

-

Strength

0.2%;10%

Approval Date

1985-12-24

88837 / 1

Active Ingredient

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Application Number

88837

Product Number

1

Dosage Form

-

Strength

0.2%;10%

Approval Date

1985-12-24

Regulatory Status

Discontinued

1985
20 Nov
Discontinued Application: 88824

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1985-11-20

88824 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

88824

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1985-11-20

Regulatory Status

Discontinued

1985
20 Nov
Discontinued Application: 88830

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG/ML

Approval Date

1985-11-20

88830 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

88830

Product Number

1

Dosage Form

-

Strength

500MG/ML

Approval Date

1985-11-20

Regulatory Status

Discontinued

2013
05 Apr
RX Application: 203168

Drug Name

PROLENSA

Product Number

1

Dosage Form

-

Strength

EQ 0.07% ACID

Approval Date

2013-04-05

203168 / 1

Active Ingredient

BROMFENAC SODIUM

Application Number

203168

Product Number

1

Dosage Form

-

Strength

EQ 0.07% ACID

Approval Date

2013-04-05

Regulatory Status

RX

2005
08 Apr
Discontinued Application: 21737

Drug Name

RETISERT

Product Number

1

Dosage Form

-

Strength

0.59MG

Approval Date

2005-04-08

21737 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

21737

Product Number

1

Dosage Form

-

Strength

0.59MG

Approval Date

2005-04-08

Regulatory Status

Discontinued

1994
28 Dec
RX Application: 40066

Drug Name

SULFACETAMIDE SODIUM

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1994-12-28

40066 / 1

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

40066

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1994-12-28

Regulatory Status

RX

1985
17 May
Discontinued Application: 88947

Drug Name

SULFACETAMIDE SODIUM

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1985-05-17

88947 / 1

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

88947

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1985-05-17

Regulatory Status

Discontinued

1995
29 Dec
RX Application: 74449

Drug Name

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 0.23% PHOSPHATE;10%

Approval Date

1995-12-29

74449 / 1

Active Ingredient

PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM

Application Number

74449

Product Number

1

Dosage Form

-

Strength

EQ 0.23% PHOSPHATE;10%

Approval Date

1995-12-29

Regulatory Status

RX

1982
13 Dec
Discontinued Application: 87949

Drug Name

SULFAIR 10

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-12-13

87949 / 1

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

87949

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-12-13

Regulatory Status

Discontinued

1982
22 Dec
Discontinued Application: 88000

Drug Name

SULFAIR 10

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-12-22

88000 / 1

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

88000

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-12-22

Regulatory Status

Discontinued

1983
13 Oct
Discontinued Application: 88385

Drug Name

SULFAIR FORTE

Product Number

1

Dosage Form

-

Strength

30%

Approval Date

1983-10-13

88385 / 1

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

88385

Product Number

1

Dosage Form

-

Strength

30%

Approval Date

1983-10-13

Regulatory Status

Discontinued

1983
25 May
Discontinued Application: 88186

Drug Name

SULFAIR-15

Product Number

1

Dosage Form

-

Strength

15%

Approval Date

1983-05-25

88186 / 1

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

88186

Product Number

1

Dosage Form

-

Strength

15%

Approval Date

1983-05-25

Regulatory Status

Discontinued

1982
28 Dec
Discontinued Application: 88089

Drug Name

SULPHRIN

Product Number

1

Dosage Form

-

Strength

0.5%;10%

Approval Date

1982-12-28

88089 / 1

Active Ingredient

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Application Number

88089

Product Number

1

Dosage Form

-

Strength

0.5%;10%

Approval Date

1982-12-28

Regulatory Status

Discontinued

1983
03 Feb
Discontinued Application: 87818

Drug Name

SULTEN-10

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1983-02-03

87818 / 1

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

87818

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1983-02-03

Regulatory Status

Discontinued

1997
25 Mar
Discontinued Application: 74776

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

1997-03-25

74776 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

74776

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

1997-03-25

Regulatory Status

Discontinued

1997
25 Mar
Discontinued Application: 74778

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

1997-03-25

74778 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

74778

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

1997-03-25

Regulatory Status

Discontinued

1982
10 Aug
Discontinued Application: 87912

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-08-10

87912 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

87912

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-08-10

Regulatory Status

Discontinued

1982
10 Aug
Discontinued Application: 87921

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1982-08-10

87921 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

87921

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

1982-08-10

Regulatory Status

Discontinued

1982
10 Aug
Discontinued Application: 87922

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-08-10

87922 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

87922

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-08-10

Regulatory Status

Discontinued

1994
27 Jul
RX Application: 40064

Drug Name

TROPICAMIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1994-07-27

40064 / 1

Active Ingredient

TROPICAMIDE

Application Number

40064

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1994-07-27

Regulatory Status

RX

1994
27 Jul
RX Application: 40067

Drug Name

TROPICAMIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1994-07-27

40067 / 1

Active Ingredient

TROPICAMIDE

Application Number

40067

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1994-07-27

Regulatory Status

RX

-
Unclassified Application: 21640

Drug Name

VITRASE

Product Number

1

Dosage Form

-

Strength

6,200 UNITS/VIAL

Approval Date

-

21640 / 1

Active Ingredient

HYALURONIDASE

Application Number

21640

Product Number

1

Dosage Form

-

Strength

6,200 UNITS/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 21640

Drug Name

VITRASE

Product Number

2

Dosage Form

-

Strength

200 UNITS/VIAL

Approval Date

-

21640 / 2

Active Ingredient

HYALURONIDASE

Application Number

21640

Product Number

2

Dosage Form

-

Strength

200 UNITS/VIAL

Approval Date

-

Regulatory Status

Unclassified

1996
04 Mar
Discontinued Application: 20569

Drug Name

VITRASERT

Product Number

1

Dosage Form

-

Strength

4.5MG

Approval Date

1996-03-04

20569 / 1

Active Ingredient

GANCICLOVIR

Application Number

20569

Product Number

1

Dosage Form

-

Strength

4.5MG

Approval Date

1996-03-04

Regulatory Status

Discontinued

2017
02 Nov
RX Application: 207795

Drug Name

VYZULTA

Product Number

1

Dosage Form

-

Strength

0.024%

Approval Date

2017-11-02

207795 / 1

Active Ingredient

LATANOPROSTENE BUNOD

Application Number

207795

Product Number

1

Dosage Form

-

Strength

0.024%

Approval Date

2017-11-02

Regulatory Status

RX

1982
02 Jul
Discontinued Application: 62389

Drug Name

ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

1982-07-02

62389 / 1

Active Ingredient

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62389

Product Number

1

Dosage Form

-

Strength

400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Approval Date

1982-07-02

Regulatory Status

Discontinued

2009
15 Sep
RX Application: 22211

Drug Name

ZIRGAN

Product Number

1

Dosage Form

-

Strength

0.15%

Approval Date

2009-09-15

22211 / 1

Active Ingredient

GANCICLOVIR

Application Number

22211

Product Number

1

Dosage Form

-

Strength

0.15%

Approval Date

2009-09-15

Regulatory Status

RX

2004
14 Dec
RX Application: 50804

Drug Name

ZYLET

Product Number

1

Dosage Form

-

Strength

0.5%;0.3%

Approval Date

2004-12-14

50804 / 1

Active Ingredient

LOTEPREDNOL ETABONATE; TOBRAMYCIN

Application Number

50804

Product Number

1

Dosage Form

-

Strength

0.5%;0.3%

Approval Date

2004-12-14

Regulatory Status

RX

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  • FDA Approved Drugs Database
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Drug Status Breakdown
114 total
  • Discontinued
  • OTC
  • RX
  • Unclassified
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

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FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE

Application Number

40063

Product Number

1

Active Ingredient

ACETIC ACID, GLACIAL; ALUMINUM ACETATE

Dosage Form

-

Strength

2%;0.79%

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

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