Details for New Drug Application (NDA): 091497
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NDA 091497 describes LOSARTAN POTASSIUM, which is a drug marketed by Aiping Pharm Inc, Alembic Pharms Ltd, Apotex, Apotex Corp, Aurobindo Pharma, Chartwell Rx, Granules, Hetero Labs Ltd V, Hikma, Hisun Pharm Hangzhou, Ipca Labs Ltd, Jubilant Cadista, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, MSN, Mylan, Prinston Inc, Strides Pharma, Teva, Torrent Pharms, Unichem, Watson Labs, Zydus Pharms Usa Inc, Sandoz, and Teva Pharms, and is included in forty-one NDAs. It is available from forty-six suppliers. Additional details are available on the LOSARTAN POTASSIUM profile page.
The generic ingredient in LOSARTAN POTASSIUM is hydrochlorothiazide; losartan potassium. There are thirty-two drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.
The generic ingredient in LOSARTAN POTASSIUM is hydrochlorothiazide; losartan potassium. There are thirty-two drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.
Summary for 091497
| Tradename: | LOSARTAN POTASSIUM |
| Applicant: | Prinston Inc |
| Ingredient: | losartan potassium |
| Patents: | 0 |
Pharmacology for NDA: 091497
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 091497
Suppliers and Packaging for NDA: 091497
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOSARTAN POTASSIUM | losartan potassium | TABLET;ORAL | 091497 | ANDA | Solco Healthcare US, LLC | 43547-360 | 43547-360-09 | 90 TABLET, FILM COATED in 1 BOTTLE (43547-360-09) |
| LOSARTAN POTASSIUM | losartan potassium | TABLET;ORAL | 091497 | ANDA | Solco Healthcare US, LLC | 43547-360 | 43547-360-11 | 1000 TABLET, FILM COATED in 1 BOTTLE (43547-360-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Jun 6, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jun 6, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jun 6, 2011 | TE: | AB | RLD: | No | ||||
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