Umedica Laboratories
FDA Approved Drugs
Umedica Laboratories
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 47
- Latest Approval Date Aug 05, 2026
- Data Source FDA
- First Approval Date May 24, 2018
Company Overview
Social Profiles
Company Snapshot
Umedica Laboratories
302, Dalamal House, 3rd Floor, J. Bajaj Road, Nariman Point, Mumbai - 400 021
India
www.umedicalabs.com/ exports@umedicalabs.com View on MapFDA Approved Drug Records ( 47 records )
Drug Name
ATORVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2020-08-19
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
213853
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2020-08-19
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2020-08-19
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
213853
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2020-08-19
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2020-08-19
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
213853
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2020-08-19
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2020-08-19
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
213853
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2020-08-19
Regulatory Status
RX
Drug Name
CARBAMAZEPINE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2020-04-15
Active Ingredient
CARBAMAZEPINE
Application Number
207798
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2020-04-15
Regulatory Status
RX
Drug Name
CARBAMAZEPINE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2020-04-15
Active Ingredient
CARBAMAZEPINE
Application Number
207798
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2020-04-15
Regulatory Status
RX
Drug Name
CARBAMAZEPINE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2022-08-18
Active Ingredient
CARBAMAZEPINE
Application Number
216594
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2022-08-18
Regulatory Status
RX
Drug Name
CARBAMAZEPINE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2022-08-18
Active Ingredient
CARBAMAZEPINE
Application Number
216594
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2022-08-18
Regulatory Status
RX
Drug Name
CARBAMAZEPINE
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
2022-08-18
Active Ingredient
CARBAMAZEPINE
Application Number
216594
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
2022-08-18
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2019-11-27
Active Ingredient
CELECOXIB
Application Number
210628
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2019-11-27
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2019-11-27
Active Ingredient
CELECOXIB
Application Number
210628
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2019-11-27
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2019-11-27
Active Ingredient
CELECOXIB
Application Number
210628
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2019-11-27
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2019-11-27
Active Ingredient
CELECOXIB
Application Number
210628
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2019-11-27
Regulatory Status
RX
Drug Name
CHLORTHALIDONE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2018-05-24
Active Ingredient
CHLORTHALIDONE
Application Number
207222
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2018-05-24
Regulatory Status
RX
Drug Name
CHLORTHALIDONE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2018-05-24
Active Ingredient
CHLORTHALIDONE
Application Number
207222
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2018-05-24
Regulatory Status
RX
Drug Name
DICLOFENAC POTASSIUM
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2022-05-11
Active Ingredient
DICLOFENAC POTASSIUM
Application Number
215750
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2022-05-11
Regulatory Status
RX
Drug Name
DICLOFENAC POTASSIUM
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2025-06-30
Active Ingredient
DICLOFENAC POTASSIUM
Application Number
215750
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2025-06-30
Regulatory Status
RX
Drug Name
DICLOFENAC POTASSIUM
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2025-08-29
Active Ingredient
DICLOFENAC POTASSIUM
Application Number
217010
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2025-08-29
Regulatory Status
RX
Drug Name
DICLOFENAC SODIUM
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2025-11-05
Active Ingredient
DICLOFENAC SODIUM
Application Number
219945
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2025-11-05
Regulatory Status
RX
Drug Name
DICLOFENAC SODIUM
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2025-11-05
Active Ingredient
DICLOFENAC SODIUM
Application Number
219945
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2025-11-05
Regulatory Status
RX
Drug Name
DICLOFENAC SODIUM
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2025-11-05
Active Ingredient
DICLOFENAC SODIUM
Application Number
219945
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2025-11-05
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2019-07-18
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
207135
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2019-07-18
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2019-07-18
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
207135
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2019-07-18
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2019-07-18
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
207135
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2019-07-18
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2019-09-17
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
208847
Product Number
1
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2019-09-17
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
25MG;40MG
Approval Date
2019-09-17
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
208847
Product Number
2
Dosage Form
-
Strength
25MG;40MG
Approval Date
2019-09-17
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2019-09-17
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
208847
Product Number
3
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2019-09-17
Regulatory Status
RX
Drug Name
RANOLAZINE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2026-08-05
Active Ingredient
RANOLAZINE
Application Number
214551
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2026-08-05
Regulatory Status
RX
Drug Name
RANOLAZINE
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2026-08-05
Active Ingredient
RANOLAZINE
Application Number
214551
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2026-08-05
Regulatory Status
RX
Drug Name
ROSUVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2019-04-09
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
207626
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2019-04-09
Regulatory Status
RX
Drug Name
ROSUVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2019-04-09
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
207626
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2019-04-09
Regulatory Status
RX
Drug Name
ROSUVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2019-04-09
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
207626
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2019-04-09
Regulatory Status
RX
Drug Name
ROSUVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2019-04-09
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
207626
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2019-04-09
Regulatory Status
RX
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
1
Dosage Form
-
Strength
24MG;26MG
Approval Date
2026-08-04
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
219946
Product Number
1
Dosage Form
-
Strength
24MG;26MG
Approval Date
2026-08-04
Regulatory Status
RX
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
2
Dosage Form
-
Strength
49MG;51MG
Approval Date
2026-08-04
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
219946
Product Number
2
Dosage Form
-
Strength
49MG;51MG
Approval Date
2026-08-04
Regulatory Status
RX
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
3
Dosage Form
-
Strength
97MG;103MG
Approval Date
2026-08-04
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
219946
Product Number
3
Dosage Form
-
Strength
97MG;103MG
Approval Date
2026-08-04
Regulatory Status
RX
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2026-01-20
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
218342
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2026-01-20
Regulatory Status
RX
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2026-01-20
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
218342
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2026-01-20
Regulatory Status
RX
Drug Name
SILDENAFIL CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2020-08-25
Active Ingredient
SILDENAFIL CITRATE
Application Number
209302
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2020-08-25
Regulatory Status
RX
Drug Name
SILDENAFIL CITRATE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2020-08-25
Active Ingredient
SILDENAFIL CITRATE
Application Number
209302
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2020-08-25
Regulatory Status
RX
Drug Name
SILDENAFIL CITRATE
Product Number
3
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2021-06-15
Active Ingredient
SILDENAFIL CITRATE
Application Number
209302
Product Number
3
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2021-06-15
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2020-10-23
Active Ingredient
TADALAFIL
Application Number
211298
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2020-10-23
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2020-10-23
Active Ingredient
TADALAFIL
Application Number
211298
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2020-10-23
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2020-10-23
Active Ingredient
TADALAFIL
Application Number
211298
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2020-10-23
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2020-10-23
Active Ingredient
TADALAFIL
Application Number
211298
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2020-10-23
Regulatory Status
RX
Drug Name
VARENICLINE TARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2026-01-09
Active Ingredient
VARENICLINE TARTRATE
Application Number
218985
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2026-01-09
Regulatory Status
RX
Drug Name
VARENICLINE TARTRATE
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2026-01-09
Active Ingredient
VARENICLINE TARTRATE
Application Number
218985
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2026-01-09
Regulatory Status
RX
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Drug Status Breakdown
47 total- RX
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
ATORVASTATIN CALCIUM
Application Number
213853
Product Number
1
Active Ingredient
ATORVASTATIN CALCIUM
Dosage Form
-
Strength
EQ 10MG BASE
FDA Approved Drug Data
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