Details for New Drug Application (NDA): 203071
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NDA 203071 describes IRBESARTAN, which is a drug marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, Chartwell Rx, Hetero Labs Ltd V, Hikma, Hisun Pharm Hangzhou, Ipca Labs Ltd, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Prinston Inc, Sandoz, Sciegen Pharms Inc, Teva Pharms, Unichem, Upsher Smith Labs, Watson Labs Inc, Zydus Pharms Usa Inc, Alembic, Atlas Pharms Llc, Dr Reddys Labs Ltd, Norvium Bioscience, and Teva, and is included in thirty-seven NDAs. It is available from twenty-one suppliers. Additional details are available on the IRBESARTAN profile page.
The generic ingredient in IRBESARTAN is hydrochlorothiazide; irbesartan. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.
The generic ingredient in IRBESARTAN is hydrochlorothiazide; irbesartan. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.
Summary for 203071
| Tradename: | IRBESARTAN |
| Applicant: | Prinston Inc |
| Ingredient: | irbesartan |
| Patents: | 0 |
Pharmacology for NDA: 203071
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 203071
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IRBESARTAN | irbesartan | TABLET;ORAL | 203071 | ANDA | Solco Healthcare U.S., LLC | 43547-374 | 43547-374-03 | 30 TABLET in 1 BOTTLE (43547-374-03) |
| IRBESARTAN | irbesartan | TABLET;ORAL | 203071 | ANDA | Solco Healthcare U.S., LLC | 43547-374 | 43547-374-09 | 90 TABLET in 1 BOTTLE (43547-374-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
| Approval Date: | Sep 27, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Sep 27, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Sep 27, 2012 | TE: | AB | RLD: | No | ||||
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