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Details for New Drug Application (NDA): 078955
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NDA 078955 describes PROPRANOLOL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Adare Pharms Inc, Inwood Labs, Mylan, Nortec Dev Assoc, Upsher Smith Labs, Zydus Pharms Usa Inc, Athenex Inc, Baxter Hlthcare Corp, Fosun Pharma, Fresenius Kabi Usa, Hikma Farmaceutica, Smith And Nephew, Solopak, Hikma, Morton Grove, Ani Pharms Inc, Dava Pharms Inc, Duramed Pharms Barr, Impax Labs Inc, Innogenix, Interpharm, Ipca Labs Ltd, Ivax Sub Teva Pharms, Lederle, Northstar Hlthcare, Par Pharm, Purepac Pharm, Roxane, Sandoz, Schering, Superpharm, Teva, Vintage Pharms, Warner Chilcott, Watson Labs, Watson Labs Teva, and Yaopharma Co Ltd, and is included in one hundred and thirty-nine NDAs. It is available from thirty-one suppliers. Additional details are available on the PROPRANOLOL HYDROCHLORIDE profile page.
The generic ingredient in PROPRANOLOL HYDROCHLORIDE is hydrochlorothiazide; propranolol hydrochloride. There are thirty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the hydrochlorothiazide; propranolol hydrochloride profile page.
The generic ingredient in PROPRANOLOL HYDROCHLORIDE is hydrochlorothiazide; propranolol hydrochloride. There are thirty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the hydrochlorothiazide; propranolol hydrochloride profile page.
Summary for 078955
| Tradename: | PROPRANOLOL HYDROCHLORIDE |
| Applicant: | Ipca Labs Ltd |
| Ingredient: | propranolol hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078955
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 078955
Suppliers and Packaging for NDA: 078955
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | TABLET;ORAL | 078955 | ANDA | Unit Dose Services | 50436-4314 | 50436-4314-2 | 60 TABLET in 1 BOTTLE (50436-4314-2) |
| PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | TABLET;ORAL | 078955 | ANDA | PD-Rx Pharmaceuticals, Inc. | 55289-234 | 55289-234-01 | 100 TABLET in 1 BOTTLE, PLASTIC (55289-234-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jun 2, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jun 2, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Jun 2, 2008 | TE: | AB | RLD: | No | ||||
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