DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 070178
» See Plans and Pricing
NDA 070178 describes PROPRANOLOL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Adare Pharms Inc, Amta, 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 forty NDAs. It is available from thirty-six 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 070178
| Tradename: | PROPRANOLOL HYDROCHLORIDE |
| Applicant: | Watson Labs |
| Ingredient: | propranolol hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 070178
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 070178
Suppliers and Packaging for NDA: 070178
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | TABLET;ORAL | 070178 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1662 | 0115-1662-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0115-1662-01) |
| PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | TABLET;ORAL | 070178 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1662 | 0115-1662-02 | 500 TABLET in 1 BOTTLE, PLASTIC (0115-1662-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | May 13, 1986 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Apr 23, 2018 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
