Details for New Drug Application (NDA): 078703
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NDA 078703 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 forty 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 078703
| Tradename: | PROPRANOLOL HYDROCHLORIDE |
| Applicant: | Adare Pharms Inc |
| Ingredient: | propranolol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078703
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 078703
Suppliers and Packaging for NDA: 078703
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 078703 | ANDA | AvKARE | 42291-522 | 42291-522-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-522-01) |
| PROPRANOLOL HYDROCHLORIDE | propranolol hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 078703 | ANDA | AvKARE | 42291-522 | 42291-522-10 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-522-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 60MG | ||||
| Approval Date: | Jul 15, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 80MG | ||||
| Approval Date: | Jul 15, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 120MG | ||||
| Approval Date: | Jul 15, 2011 | TE: | AB | RLD: | No | ||||
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