FDC
FDA Approved Drugs
FDC
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.
- Total Records 21
- Latest Approval Date May 14, 2026
- Data Source FDA
- First Approval Date Apr 30, 2008
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FDC
B - 8 MIDC area, Waluj - 431 136 District - Aurangabad, Maharashtra
India
www.fdcindia.com/ contact@fdcindia.com View on MapFDA Approved Drug Records ( 21 records )
Drug Name
CEFIXIME
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2024-12-17
Active Ingredient
CEFIXIME
Application Number
206358
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2024-12-17
Regulatory Status
RX
Drug Name
CEFIXIME
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2026-05-14
Active Ingredient
CEFIXIME
Application Number
218691
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2026-05-14
Regulatory Status
RX
Drug Name
CEFIXIME
Product Number
2
Dosage Form
-
Strength
200MG/5ML
Approval Date
2026-05-14
Active Ingredient
CEFIXIME
Application Number
218691
Product Number
2
Dosage Form
-
Strength
200MG/5ML
Approval Date
2026-05-14
Regulatory Status
RX
Drug Name
CIPROFLOXACIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.3% BASE
Approval Date
2008-06-30
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
Drug Name
DORZOLAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
2019-01-24
Active Ingredient
DORZOLAMIDE HYDROCHLORIDE
Application Number
205294
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
2019-01-24
Regulatory Status
RX
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
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
Drug Name
FLUCONAZOLE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2026-01-08
Active Ingredient
FLUCONAZOLE
Application Number
218692
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2026-01-08
Regulatory Status
RX
Drug Name
FLUCONAZOLE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2026-01-08
Active Ingredient
FLUCONAZOLE
Application Number
218692
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2026-01-08
Regulatory Status
RX
Drug Name
FLUCONAZOLE
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2026-01-08
Active Ingredient
FLUCONAZOLE
Application Number
218692
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2026-01-08
Regulatory Status
RX
Drug Name
FLUCONAZOLE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2026-01-08
Active Ingredient
FLUCONAZOLE
Application Number
218692
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2026-01-08
Regulatory Status
RX
Drug Name
LATANOPROST
Product Number
1
Dosage Form
-
Strength
0.005%
Approval Date
2016-04-22
Active Ingredient
LATANOPROST
Application Number
202442
Product Number
1
Dosage Form
-
Strength
0.005%
Approval Date
2016-04-22
Regulatory Status
RX
Drug Name
MOXIFLOXACIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2025-08-04
Active Ingredient
MOXIFLOXACIN HYDROCHLORIDE
Application Number
219475
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2025-08-04
Regulatory Status
Discontinued
Drug Name
OFLOXACIN
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2009-02-25
Active Ingredient
OFLOXACIN
Application Number
78559
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2009-02-25
Regulatory Status
RX
Drug Name
OFLOXACIN
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2022-01-19
Active Ingredient
OFLOXACIN
Application Number
215038
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2022-01-19
Regulatory Status
RX
Drug Name
OLOPATADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE
Approval Date
2019-09-26
Active Ingredient
OLOPATADINE HYDROCHLORIDE
Application Number
209282
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE
Approval Date
2019-09-26
Regulatory Status
Discontinued
Drug Name
OLOPATADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.2% BASE
Approval Date
2025-07-14
Active Ingredient
OLOPATADINE HYDROCHLORIDE
Application Number
217051
Product Number
1
Dosage Form
-
Strength
EQ 0.2% BASE
Approval Date
2025-07-14
Regulatory Status
Discontinued
Drug Name
PILOCARPINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2025-10-02
Active Ingredient
PILOCARPINE HYDROCHLORIDE
Application Number
217052
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2025-10-02
Regulatory Status
Discontinued
Drug Name
PILOCARPINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
2%
Approval Date
2025-10-02
Active Ingredient
PILOCARPINE HYDROCHLORIDE
Application Number
217052
Product Number
2
Dosage Form
-
Strength
2%
Approval Date
2025-10-02
Regulatory Status
Discontinued
Drug Name
PILOCARPINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
4%
Approval Date
2025-10-02
Active Ingredient
PILOCARPINE HYDROCHLORIDE
Application Number
217052
Product Number
3
Dosage Form
-
Strength
4%
Approval Date
2025-10-02
Regulatory Status
Discontinued
Drug Name
TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
2008-04-30
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
Drug Name
TIMOLOL MALEATE
Product Number
2
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2008-04-30
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
Drug Status Breakdown
21 total- RX
- Discontinued
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
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Drug Name
CEFIXIME
Application Number
206358
Product Number
1
Active Ingredient
CEFIXIME
Dosage Form
-
Strength
400MG
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