ANDA Repository RX
FDA Approved Drugs

ANDA Repository RX

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
  • Total Records 27
  • Latest Approval Date Jul 28, 2023
  • Data Source FDA
  • First Approval Date Jan 27, 1994
All
33
View
Discontinued
6
View
RX
27
View
Company Overview

Company

ANDA Repository RX

Country

U.S.A

Website

Visit Website

Email

info@andarepository.com

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Company Snapshot

ANDA Repository RX

3411 Silverside Road Tatnall Building Ste 104, Wilmington, New Castle, De, 19810

U.S.A

www.andarepository.com/ info@andarepository.com View on Map
FDA Approved Drug Records ( 27 records )
2016
15 Nov
RX Application: 207386

Drug Name

BUTALBITAL AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;50MG

Approval Date

2016-11-15

207386 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Application Number

207386

Product Number

1

Dosage Form

-

Strength

300MG;50MG

Approval Date

2016-11-15

Regulatory Status

RX

2023
28 Jul
RX Application: 203973

Drug Name

CALCITRIOL

Product Number

1

Dosage Form

-

Strength

1MCG/ML

Approval Date

2023-07-28

203973 / 1

Active Ingredient

CALCITRIOL

Application Number

203973

Product Number

1

Dosage Form

-

Strength

1MCG/ML

Approval Date

2023-07-28

Regulatory Status

RX

2007
18 Jul
RX Application: 65418

Drug Name

CEFDINIR

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2007-07-18

65418 / 1

Active Ingredient

CEFDINIR

Application Number

65418

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2007-07-18

Regulatory Status

RX

2007
18 Jul
RX Application: 65429

Drug Name

CEFDINIR

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2007-07-18

65429 / 1

Active Ingredient

CEFDINIR

Application Number

65429

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2007-07-18

Regulatory Status

RX

2007
18 Jul
RX Application: 65429

Drug Name

CEFDINIR

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

2007-07-18

65429 / 2

Active Ingredient

CEFDINIR

Application Number

65429

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

2007-07-18

Regulatory Status

RX

2007
14 Nov
RX Application: 65388

Drug Name

CEFPODOXIME PROXETIL

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2007-11-14

65388 / 1

Active Ingredient

CEFPODOXIME PROXETIL

Application Number

65388

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2007-11-14

Regulatory Status

RX

2007
14 Nov
RX Application: 65388

Drug Name

CEFPODOXIME PROXETIL

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2007-11-14

65388 / 2

Active Ingredient

CEFPODOXIME PROXETIL

Application Number

65388

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2007-11-14

Regulatory Status

RX

2017
20 Jan
RX Application: 91117

Drug Name

CEFTRIAXONE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2017-01-20

91117 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

91117

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2017-01-20

Regulatory Status

RX

2008
15 Feb
RX Application: 65359

Drug Name

CEFUROXIME AXETIL

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

2008-02-15

65359 / 1

Active Ingredient

CEFUROXIME AXETIL

Application Number

65359

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

2008-02-15

Regulatory Status

RX

2008
15 Feb
RX Application: 65359

Drug Name

CEFUROXIME AXETIL

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2008-02-15

65359 / 2

Active Ingredient

CEFUROXIME AXETIL

Application Number

65359

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2008-02-15

Regulatory Status

RX

2008
15 Feb
RX Application: 65359

Drug Name

CEFUROXIME AXETIL

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2008-02-15

65359 / 3

Active Ingredient

CEFUROXIME AXETIL

Application Number

65359

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2008-02-15

Regulatory Status

RX

2005
28 Jun
RX Application: 65248

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2005-06-28

65248 / 1

Active Ingredient

CEPHALEXIN

Application Number

65248

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2005-06-28

Regulatory Status

RX

2005
28 Jun
RX Application: 65248

Drug Name

CEPHALEXIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2005-06-28

65248 / 2

Active Ingredient

CEPHALEXIN

Application Number

65248

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2005-06-28

Regulatory Status

RX

2010
01 Jun
RX Application: 40861

Drug Name

CHLORZOXAZONE

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2010-06-01

40861 / 1

Active Ingredient

CHLORZOXAZONE

Application Number

40861

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2010-06-01

Regulatory Status

RX

2010
01 Jun
RX Application: 40861

Drug Name

CHLORZOXAZONE

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2010-06-01

40861 / 2

Active Ingredient

CHLORZOXAZONE

Application Number

40861

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2010-06-01

Regulatory Status

RX

2016
24 Jun
RX Application: 207483

Drug Name

CHLORZOXAZONE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2016-06-24

207483 / 1

Active Ingredient

CHLORZOXAZONE

Application Number

207483

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2016-06-24

Regulatory Status

RX

2018
11 Apr
RX Application: 210736

Drug Name

FLAC

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2018-04-11

210736 / 1

Active Ingredient

FLUOCINOLONE ACETONIDE

Application Number

210736

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2018-04-11

Regulatory Status

RX

2016
23 Feb
RX Application: 204511

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2016-02-23

204511 / 1

Active Ingredient

LEVETIRACETAM

Application Number

204511

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2016-02-23

Regulatory Status

RX

2016
23 Feb
RX Application: 204511

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2016-02-23

204511 / 2

Active Ingredient

LEVETIRACETAM

Application Number

204511

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2016-02-23

Regulatory Status

RX

1994
27 Jan
RX Application: 40062

Drug Name

METHAZOLAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1994-01-27

40062 / 1

Active Ingredient

METHAZOLAMIDE

Application Number

40062

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1994-01-27

Regulatory Status

RX

1994
27 Jan
RX Application: 40062

Drug Name

METHAZOLAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1994-01-27

40062 / 2

Active Ingredient

METHAZOLAMIDE

Application Number

40062

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1994-01-27

Regulatory Status

RX

2020
10 Apr
RX Application: 210764

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2020-04-10

210764 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

210764

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2020-04-10

Regulatory Status

RX

2020
10 Apr
RX Application: 210764

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG/5ML

Approval Date

2020-04-10

210764 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

210764

Product Number

2

Dosage Form

-

Strength

10MG/5ML

Approval Date

2020-04-10

Regulatory Status

RX

2007
26 Jan
RX Application: 78065

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2007-01-26

78065 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

78065

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2007-01-26

Regulatory Status

RX

2007
26 Jan
RX Application: 78065

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2007-01-26

78065 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

78065

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2007-01-26

Regulatory Status

RX

2007
26 Jan
RX Application: 78065

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2007-01-26

78065 / 3

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

78065

Product Number

3

Dosage Form

-

Strength

120MG

Approval Date

2007-01-26

Regulatory Status

RX

2007
26 Jan
RX Application: 78065

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

2007-01-26

78065 / 4

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

78065

Product Number

4

Dosage Form

-

Strength

160MG

Approval Date

2007-01-26

Regulatory Status

RX

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Drug Status Breakdown
27 total
  • RX
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

BUTALBITAL AND ACETAMINOPHEN

Application Number

207386

Product Number

1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Dosage Form

-

Strength

300MG;50MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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