Details for New Drug Application (NDA): 071976
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NDA 071976 describes PROPRANOLOL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Adare Pharms Inc, Amta, Inwood Labs, Lupin Ltd, Mylan, Nortec Dev Assoc, Upsher Smith Labs, Zydus Pharms Usa Inc, Baxter Hlthcare Corp, Chartwell Injectable, Fosun Pharma, Fresenius Kabi Usa, Hikma Farmaceutica, Smith And Nephew, Solopak, Hikma, Pai Holdings Pharm, Ani Pharms, Chartwell Rx, Dava Pharms Inc, Duramed Pharms Barr, Impax Labs Inc, Innogenix, Interpharm, Ipca Labs Ltd, Ivax Sub Teva Pharms, Lederle, Northstar Hlthcare, Purepac Pharm, Roxane, Sandoz, Schering, Strides Pharma, Superpharm, Teva, Vintage Pharms, Warner Chilcott, Watson Labs, Watson Labs Teva, and Rising, and is included in one hundred and thirty-eight NDAs. It is available from thirty-seven 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. 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. Additional details are available on the hydrochlorothiazide; propranolol hydrochloride profile page.
Summary for 071976
| Tradename: | PROPRANOLOL HYDROCHLORIDE |
| Applicant: | Impax Labs Inc |
| Ingredient: | propranolol hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 071976
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 071976
Suppliers and Packaging for NDA: 071976
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | TABLET;ORAL | 071976 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2080 | 69238-2080-1 | 100 TABLET in 1 BOTTLE (69238-2080-1) |
| PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | TABLET;ORAL | 071976 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2081 | 69238-2081-1 | 100 TABLET in 1 BOTTLE (69238-2081-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Apr 6, 1988 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | May 13, 1986 | TE: | AB | RLD: | No | ||||
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