Alcon Inc
FDA Approved Drugs

Alcon Inc

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.

RX Discontinued Unclassified OTC
  • Total Records 60
  • Latest Approval Date May 28, 2025
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
60
View
Unclassified
1
View
Discontinued
34
View
OTC
5
View
RX
20
View
Company Overview

Company

Alcon Inc

Country

U.S.A

Website

Visit Website

Email

alcon@alconpharma.com

Social Profiles

LinkedIn
Company Snapshot

Alcon Inc

6201 South Freeway Mail Code AB2-6 Fort Worth, TX 76134-2001

U.S.A

www.alcon.com/ alcon@alconpharma.com View on Map
FDA Approved Drug Records ( 60 records )
1982
01 Jan
RX Application: 80027

Drug Name

ALCAINE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

80027 / 1

Active Ingredient

PROPARACAINE HYDROCHLORIDE

Application Number

80027

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

RX

1986
17 Dec
RX Application: 18634

Drug Name

BETADINE

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

1986-12-17

18634 / 1

Active Ingredient

POVIDONE-IODINE

Application Number

18634

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

1986-12-17

Regulatory Status

RX

2000
23 Feb
Discontinued Application: 21114

Drug Name

BETAXON

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2000-02-23

21114 / 1

Active Ingredient

LEVOBETAXOLOL HYDROCHLORIDE

Application Number

21114

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2000-02-23

Regulatory Status

Discontinued

1997
17 Apr
Discontinued Application: 20619

Drug Name

BETOPTIC PILO

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE;1.75%

Approval Date

1997-04-17

20619 / 1

Active Ingredient

BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE

Application Number

20619

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE;1.75%

Approval Date

1997-04-17

Regulatory Status

Discontinued

-
Unclassified Application: 91574

Drug Name

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

0.2%; 0.5%

Approval Date

-

91574 / 1

Active Ingredient

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Application Number

91574

Product Number

1

Dosage Form

-

Strength

0.2%; 0.5%

Approval Date

-

Regulatory Status

Unclassified

1997
10 Dec
RX Application: 20742

Drug Name

BSS

Product Number

1

Dosage Form

-

Strength

0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML

Approval Date

1997-12-10

20742 / 1

Active Ingredient

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE

Application Number

20742

Product Number

1

Dosage Form

-

Strength

0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML

Approval Date

1997-12-10

Regulatory Status

RX

1982
01 Jan
RX Application: 18469

Drug Name

BSS PLUS

Product Number

1

Dosage Form

-

Strength

0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML

Approval Date

1982-01-01

18469 / 1

Active Ingredient

CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE

Application Number

18469

Product Number

1

Dosage Form

-

Strength

0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80021

Drug Name

CETAMIDE

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-01-01

80021 / 1

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

80021

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1993
06 Aug
Discontinued Application: 87771

Drug Name

CETAPRED

Product Number

1

Dosage Form

-

Strength

0.25%;10%

Approval Date

1993-08-06

87771 / 1

Active Ingredient

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Application Number

87771

Product Number

1

Dosage Form

-

Strength

0.25%;10%

Approval Date

1993-08-06

Regulatory Status

Discontinued

1985
25 Sep
Discontinued Application: 62628

Drug Name

CHLORAMPHENICOL

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1985-09-25

62628 / 1

Active Ingredient

CHLORAMPHENICOL

Application Number

62628

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1985-09-25

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 84108

Drug Name

CYCLOGYL

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

84108 / 1

Active Ingredient

CYCLOPENTOLATE HYDROCHLORIDE

Application Number

84108

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 84109

Drug Name

CYCLOGYL

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

84109 / 1

Active Ingredient

CYCLOPENTOLATE HYDROCHLORIDE

Application Number

84109

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 84110

Drug Name

CYCLOGYL

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

84110 / 1

Active Ingredient

CYCLOPENTOLATE HYDROCHLORIDE

Application Number

84110

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 84300

Drug Name

CYCLOMYDRIL

Product Number

1

Dosage Form

-

Strength

0.2%;1%

Approval Date

1982-01-01

84300 / 1

Active Ingredient

CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE

Application Number

84300

Product Number

1

Dosage Form

-

Strength

0.2%;1%

Approval Date

1982-01-01

Regulatory Status

RX

1991
24 Jan
Discontinued Application: 89162

Drug Name

CYCLOPENTOLATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1991-01-24

89162 / 1

Active Ingredient

CYCLOPENTOLATE HYDROCHLORIDE

Application Number

89162

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1991-01-24

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14169

Drug Name

DENDRID

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

14169 / 1

Active Ingredient

IDOXURIDINE

Application Number

14169

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61645

Drug Name

ECONOCHLOR

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

61645 / 1

Active Ingredient

CHLORAMPHENICOL

Application Number

61645

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61648

Drug Name

ECONOCHLOR

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

61648 / 1

Active Ingredient

CHLORAMPHENICOL

Application Number

61648

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

2020
26 Oct
RX Application: 210933

Drug Name

EYSUVIS

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2020-10-26

210933 / 1

Active Ingredient

LOTEPREDNOL ETABONATE

Application Number

210933

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2020-10-26

Regulatory Status

RX

2006
28 Mar
RX Application: 21980

Drug Name

FLUORESCITE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Approval Date

2006-03-28

21980 / 1

Active Ingredient

FLUORESCEIN SODIUM

Application Number

21980

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Approval Date

2006-03-28

Regulatory Status

RX

1985
25 Nov
Discontinued Application: 62523

Drug Name

GENTAMICIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1985-11-25

62523 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62523

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

1985-11-25

Regulatory Status

Discontinued

2018
22 Aug
RX Application: 210565

Drug Name

INVELTYS

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2018-08-22

210565 / 1

Active Ingredient

LOTEPREDNOL ETABONATE

Application Number

210565

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2018-08-22

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 17063

Drug Name

ISMOTIC

Product Number

1

Dosage Form

-

Strength

100GM/220ML

Approval Date

1982-01-01

17063 / 1

Active Ingredient

ISOSORBIDE

Application Number

17063

Product Number

1

Dosage Form

-

Strength

100GM/220ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2016
01 Dec
RX Application: 208151

Drug Name

ISOPTO ATROPINE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2016-12-01

208151 / 1

Active Ingredient

ATROPINE SULFATE

Application Number

208151

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2016-12-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80020

Drug Name

ISOPTO CETAMIDE

Product Number

2

Dosage Form

-

Strength

15%

Approval Date

1982-01-01

80020 / 2

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

80020

Product Number

2

Dosage Form

-

Strength

15%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87547

Drug Name

ISOPTO CETAPRED

Product Number

1

Dosage Form

-

Strength

0.25%;10%

Approval Date

1982-01-01

87547 / 1

Active Ingredient

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

Application Number

87547

Product Number

1

Dosage Form

-

Strength

0.25%;10%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
28 Oct
Discontinued Application: 74851

Drug Name

LEVOBUNOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1996-10-28

74851 / 1

Active Ingredient

LEVOBUNOLOL HYDROCHLORIDE

Application Number

74851

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1996-10-28

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83342

Drug Name

MAXIDEX

Product Number

1

Dosage Form

-

Strength

EQ 0.05% PHOSPHATE

Approval Date

1982-01-01

83342 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Application Number

83342

Product Number

1

Dosage Form

-

Strength

EQ 0.05% PHOSPHATE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 16968

Drug Name

MIOSTAT

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1982-01-01

16968 / 1

Active Ingredient

CARBACHOL

Application Number

16968

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 12111

Drug Name

MYDRIACYL

Product Number

2

Dosage Form

-

Strength

0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12111 / 2

Active Ingredient

TROPICAMIDE

Application Number

12111

Product Number

2

Dosage Form

-

Strength

0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12111

Drug Name

MYDRIACYL

Product Number

4

Dosage Form

-

Strength

1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12111 / 4

Active Ingredient

TROPICAMIDE

Application Number

12111

Product Number

4

Dosage Form

-

Strength

1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 84306

Drug Name

MYDRIACYL

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

84306 / 1

Active Ingredient

TROPICAMIDE

Application Number

84306

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80229

Drug Name

NAPHCON FORTE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

80229 / 1

Active Ingredient

NAPHAZOLINE HYDROCHLORIDE

Application Number

80229

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1994
08 Jun
OTC Application: 20226

Drug Name

NAPHCON-A

Product Number

1

Dosage Form

-

Strength

0.025%;0.3%

Approval Date

1994-06-08

20226 / 1

Active Ingredient

NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE

Application Number

20226

Product Number

1

Dosage Form

-

Strength

0.025%;0.3%

Approval Date

1994-06-08

Regulatory Status

OTC

2008
24 Jul
Discontinued Application: 22193

Drug Name

NAVSTEL

Product Number

1

Dosage Form

-

Strength

0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML

Approval Date

2008-07-24

22193 / 1

Active Ingredient

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE

Application Number

22193

Product Number

1

Dosage Form

-

Strength

0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML

Approval Date

2008-07-24

Regulatory Status

Discontinued

1986
17 Nov
Discontinued Application: 62721

Drug Name

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1986-11-17

62721 / 1

Active Ingredient

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62721

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1986-11-17

Regulatory Status

Discontinued

1986
21 Jul
Discontinued Application: 62714

Drug Name

NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML

Approval Date

1986-07-21

62714 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE

Application Number

62714

Product Number

1

Dosage Form

-

Strength

EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML

Approval Date

1986-07-21

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5319

Drug Name

PANTOPAQUE

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1982-01-01

5319 / 1

Active Ingredient

IOPHENDYLATE

Application Number

5319

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004
22 Dec
OTC Application: 21545

Drug Name

PATADAY ONCE DAILY RELIEF

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE

Approval Date

2004-12-22

21545 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

21545

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE

Approval Date

2004-12-22

Regulatory Status

OTC

2015
30 Jan
OTC Application: 206276

Drug Name

PATADAY ONCE DAILY RELIEF

Product Number

1

Dosage Form

-

Strength

EQ 0.7% BASE

Approval Date

2015-01-30

206276 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

206276

Product Number

1

Dosage Form

-

Strength

EQ 0.7% BASE

Approval Date

2015-01-30

Regulatory Status

OTC

1996
18 Dec
OTC Application: 20688

Drug Name

PATADAY TWICE DAILY RELIEF

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1996-12-18

20688 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

20688

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

1996-12-18

Regulatory Status

OTC

2015
15 Jan
RX Application: 207926

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

2015-01-15

207926 / 1

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

207926

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

2015-01-15

Regulatory Status

RX

2015
15 Jan
RX Application: 207926

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10%

Approval Date

2015-01-15

207926 / 2

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

207926

Product Number

2

Dosage Form

-

Strength

10%

Approval Date

2015-01-15

Regulatory Status

RX

1984
01 Oct
Discontinued Application: 18796

Drug Name

PILOPINE HS

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1984-10-01

18796 / 1

Active Ingredient

PILOCARPINE HYDROCHLORIDE

Application Number

18796

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1984-10-01

Regulatory Status

Discontinued

1991
24 Oct
Discontinued Application: 81043

Drug Name

PREDNISOLONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 0.11% PHOSPHATE

Approval Date

1991-10-24

81043 / 1

Active Ingredient

PREDNISOLONE SODIUM PHOSPHATE

Application Number

81043

Product Number

1

Dosage Form

-

Strength

EQ 0.11% PHOSPHATE

Approval Date

1991-10-24

Regulatory Status

Discontinued

1991
24 Oct
Discontinued Application: 81044

Drug Name

PREDNISOLONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 0.9% PHOSPHATE

Approval Date

1991-10-24

81044 / 1

Active Ingredient

PREDNISOLONE SODIUM PHOSPHATE

Application Number

81044

Product Number

1

Dosage Form

-

Strength

EQ 0.9% PHOSPHATE

Approval Date

1991-10-24

Regulatory Status

Discontinued

1988
23 Dec
Discontinued Application: 19387

Drug Name

PROFENAL

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1988-12-23

19387 / 1

Active Ingredient

SUPROFEN

Application Number

19387

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1988-12-23

Regulatory Status

Discontinued

2017
18 Dec
RX Application: 208254

Drug Name

RHOPRESSA

Product Number

1

Dosage Form

-

Strength

EQ 0.02% BASE

Approval Date

2017-12-18

208254 / 1

Active Ingredient

NETARSUDIL MESYLATE

Application Number

208254

Product Number

1

Dosage Form

-

Strength

EQ 0.02% BASE

Approval Date

2017-12-18

Regulatory Status

RX

2019
12 Mar
RX Application: 208259

Drug Name

ROCKLATAN

Product Number

1

Dosage Form

-

Strength

0.005%;EQ 0.02% BASE

Approval Date

2019-03-12

208259 / 1

Active Ingredient

LATANOPROST; NETARSUDIL DIMESYLATE

Application Number

208259

Product Number

1

Dosage Form

-

Strength

0.005%;EQ 0.02% BASE

Approval Date

2019-03-12

Regulatory Status

RX

2013
19 Apr
RX Application: 204251

Drug Name

SIMBRINZA

Product Number

1

Dosage Form

-

Strength

0.2%;1%

Approval Date

2013-04-19

204251 / 1

Active Ingredient

BRIMONIDINE TARTRATE; BRINZOLAMIDE

Application Number

204251

Product Number

1

Dosage Form

-

Strength

0.2%;1%

Approval Date

2013-04-19

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 50344

Drug Name

STATROL

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

50344 / 2

Active Ingredient

NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

50344

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50456

Drug Name

STATROL

Product Number

1

Dosage Form

-

Strength

EQ 3.5MG BASE/ML;16,250 UNITS/ML

Approval Date

1982-01-01

50456 / 1

Active Ingredient

NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

50456

Product Number

1

Dosage Form

-

Strength

EQ 3.5MG BASE/ML;16,250 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
30 Nov
Discontinued Application: 62339

Drug Name

STATROL

Product Number

1

Dosage Form

-

Strength

EQ 3.5MG BASE/ML;16,250 UNITS/ML

Approval Date

1984-11-30

62339 / 1

Active Ingredient

NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Application Number

62339

Product Number

1

Dosage Form

-

Strength

EQ 3.5MG BASE/ML;16,250 UNITS/ML

Approval Date

1984-11-30

Regulatory Status

Discontinued

1987
05 May
Discontinued Application: 89068

Drug Name

SULFACETAMIDE SODIUM

Product Number

1

Dosage Form

-

Strength

30%

Approval Date

1987-05-05

89068 / 1

Active Ingredient

SULFACETAMIDE SODIUM

Application Number

89068

Product Number

1

Dosage Form

-

Strength

30%

Approval Date

1987-05-05

Regulatory Status

Discontinued

1994
25 May
Discontinued Application: 63176

Drug Name

TOBRAMYCIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

1994-05-25

63176 / 1

Active Ingredient

TOBRAMYCIN

Application Number

63176

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

1994-05-25

Regulatory Status

Discontinued

2001
16 Mar
Discontinued Application: 21257

Drug Name

TRAVATAN

Product Number

1

Dosage Form

-

Strength

0.004% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-03-16

21257 / 1

Active Ingredient

TRAVOPROST

Application Number

21257

Product Number

1

Dosage Form

-

Strength

0.004% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-03-16

Regulatory Status

Discontinued

1990
28 Dec
Discontinued Application: 89172

Drug Name

TROPICAMIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1990-12-28

89172 / 1

Active Ingredient

TROPICAMIDE

Application Number

89172

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1990-12-28

Regulatory Status

Discontinued

2025
28 May
RX Application: 217370

Drug Name

TRYPTYR

Product Number

1

Dosage Form

-

Strength

0.003%

Approval Date

2025-05-28

217370 / 1

Active Ingredient

ACOLTREMON

Application Number

217370

Product Number

1

Dosage Form

-

Strength

0.003%

Approval Date

2025-05-28

Regulatory Status

RX

2006
19 Oct
Discontinued Application: 21066

Drug Name

ZADITOR

Product Number

2

Dosage Form

-

Strength

EQ 0.025% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-10-19

21066 / 2

Active Ingredient

KETOTIFEN FUMARATE

Application Number

21066

Product Number

2

Dosage Form

-

Strength

EQ 0.025% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-10-19

Regulatory Status

Discontinued

2008
02 Sep
OTC Application: 77200

Drug Name

ZADITOR

Product Number

1

Dosage Form

-

Strength

EQ 0.025% BASE

Approval Date

2008-09-02

77200 / 1

Active Ingredient

KETOTIFEN FUMARATE

Application Number

77200

Product Number

1

Dosage Form

-

Strength

EQ 0.025% BASE

Approval Date

2008-09-02

Regulatory Status

OTC

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Drug Status Breakdown
60 total
  • RX
  • Discontinued
  • Unclassified
  • OTC
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

ALCAINE

Application Number

80027

Product Number

1

Active Ingredient

PROPARACAINE HYDROCHLORIDE

Dosage Form

-

Strength

0.5%

FDA Approved Drug Data

Approved drug product information

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