Details for New Drug Application (NDA): 202130
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The generic ingredient in TELMISARTAN is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for 202130
Tradename: | TELMISARTAN |
Applicant: | Alembic |
Ingredient: | telmisartan |
Patents: | 0 |
Pharmacology for NDA: 202130
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 202130
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TELMISARTAN | telmisartan | TABLET;ORAL | 202130 | ANDA | medsource pharmaceuticals | 45865-836 | 45865-836-60 | 60 TABLET in 1 BOTTLE (45865-836-60) |
TELMISARTAN | telmisartan | TABLET;ORAL | 202130 | ANDA | Alembic Pharmaceuticals Limited | 46708-608 | 46708-608-10 | 100 TABLET in 1 CARTON (46708-608-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Jul 7, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Jul 7, 2014 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Jul 7, 2014 | TE: | AB | RLD: | No |
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