FDC RX
FDA Approved Drugs

FDC 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 15
  • Latest Approval Date May 14, 2026
  • Data Source FDA
  • First Approval Date Apr 30, 2008
All
21
View
Discontinued
6
View
RX
15
View
Company Overview

Company

FDC RX

Country

India

Website

Visit Website

Email

contact@fdcindia.com

Social Profiles

LinkedIn
Company Snapshot

FDC RX

B - 8 MIDC area, Waluj - 431 136 District - Aurangabad, Maharashtra

India

www.fdcindia.com/ contact@fdcindia.com View on Map
FDA Approved Drug Records ( 15 records )
2024
17 Dec
RX Application: 206358

Drug Name

CEFIXIME

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2024-12-17

206358 / 1

Active Ingredient

CEFIXIME

Application Number

206358

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2024-12-17

Regulatory Status

RX

2026
14 May
RX Application: 218691

Drug Name

CEFIXIME

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2026-05-14

218691 / 1

Active Ingredient

CEFIXIME

Application Number

218691

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2026-05-14

Regulatory Status

RX

2026
14 May
RX Application: 218691

Drug Name

CEFIXIME

Product Number

2

Dosage Form

-

Strength

200MG/5ML

Approval Date

2026-05-14

218691 / 2

Active Ingredient

CEFIXIME

Application Number

218691

Product Number

2

Dosage Form

-

Strength

200MG/5ML

Approval Date

2026-05-14

Regulatory Status

RX

2008
30 Jun
RX Application: 77568

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

2008-06-30

77568 / 1

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

77568

Product Number

1

Dosage Form

-

Strength

EQ 0.3% BASE

Approval Date

2008-06-30

Regulatory Status

RX

2019
24 Jan
RX Application: 205294

Drug Name

DORZOLAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2019-01-24

205294 / 1

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE

Application Number

205294

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2019-01-24

Regulatory Status

RX

2019
13 Jun
RX Application: 205295

Drug Name

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2019-06-13

205295 / 1

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Application Number

205295

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2019-06-13

Regulatory Status

RX

2026
08 Jan
RX Application: 218692

Drug Name

FLUCONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2026-01-08

218692 / 1

Active Ingredient

FLUCONAZOLE

Application Number

218692

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2026-01-08

Regulatory Status

RX

2026
08 Jan
RX Application: 218692

Drug Name

FLUCONAZOLE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2026-01-08

218692 / 2

Active Ingredient

FLUCONAZOLE

Application Number

218692

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2026-01-08

Regulatory Status

RX

2026
08 Jan
RX Application: 218692

Drug Name

FLUCONAZOLE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2026-01-08

218692 / 3

Active Ingredient

FLUCONAZOLE

Application Number

218692

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2026-01-08

Regulatory Status

RX

2026
08 Jan
RX Application: 218692

Drug Name

FLUCONAZOLE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2026-01-08

218692 / 4

Active Ingredient

FLUCONAZOLE

Application Number

218692

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2026-01-08

Regulatory Status

RX

2016
22 Apr
RX Application: 202442

Drug Name

LATANOPROST

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2016-04-22

202442 / 1

Active Ingredient

LATANOPROST

Application Number

202442

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2016-04-22

Regulatory Status

RX

2009
25 Feb
RX Application: 78559

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2009-02-25

78559 / 1

Active Ingredient

OFLOXACIN

Application Number

78559

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2009-02-25

Regulatory Status

RX

2022
19 Jan
RX Application: 215038

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2022-01-19

215038 / 1

Active Ingredient

OFLOXACIN

Application Number

215038

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2022-01-19

Regulatory Status

RX

2008
30 Apr
RX Application: 77259

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

2008-04-30

77259 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

77259

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

2008-04-30

Regulatory Status

RX

2008
30 Apr
RX Application: 77259

Drug Name

TIMOLOL MALEATE

Product Number

2

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2008-04-30

77259 / 2

Active Ingredient

TIMOLOL MALEATE

Application Number

77259

Product Number

2

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2008-04-30

Regulatory Status

RX

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Drug Status Breakdown
15 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

CEFIXIME

Application Number

206358

Product Number

1

Active Ingredient

CEFIXIME

Dosage Form

-

Strength

400MG

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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