Details for New Drug Application (NDA): 091351
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The generic ingredient in TELMISARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for 091351
Tradename: | TELMISARTAN AND HYDROCHLOROTHIAZIDE |
Applicant: | Lupin Ltd |
Ingredient: | hydrochlorothiazide; telmisartan |
Patents: | 0 |
Pharmacology for NDA: 091351
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 091351
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TELMISARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; telmisartan | TABLET;ORAL | 091351 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-193 | 68180-193-06 | 30 TABLET in 1 BOTTLE (68180-193-06) |
TELMISARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; telmisartan | TABLET;ORAL | 091351 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-194 | 68180-194-06 | 30 TABLET in 1 BOTTLE (68180-194-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;40MG | ||||
Approval Date: | Aug 7, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;80MG | ||||
Approval Date: | Aug 7, 2014 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;80MG | ||||
Approval Date: | Aug 7, 2014 | TE: | AB | RLD: | No |
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