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, Amta, Inwood Labs, Lupin Ltd, Nortec Dev Assoc, Rising, 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, Aiping Pharm Inc, Ani Pharms, Chartwell Rx, Dava Pharms Inc, Duramed Pharms Barr, Endo Operations, Impax Labs Inc, Innogenix, Interpharm, Ipca Labs Ltd, Ivax Sub Teva Pharms, Lederle, Mylan, Northstar Hlthcare, Purepac Pharm, Roxane, Sandoz, Schering, Superpharm, Teva, Warner Chilcott, Watson Labs, and Watson Labs Teva, and is included in one hundred and thirty-eight NDAs. It is available from thirty-nine 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 078955
| Tradename: | PROPRANOLOL HYDROCHLORIDE |
| Applicant: | Ipca Labs Ltd |
| Ingredient: | propranolol hydrochloride |
| Patents: | 0 |
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 | Proficient Rx LP | 63187-839 | 63187-839-03 | 3 TABLET in 1 BOTTLE (63187-839-03) |
| PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | TABLET;ORAL | 078955 | ANDA | Proficient Rx LP | 63187-839 | 63187-839-30 | 30 TABLET in 1 BOTTLE (63187-839-30) |
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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