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Details for New Drug Application (NDA): 062936
NDA 062936 describes PENICILLIN V POTASSIUM, which is a drug marketed by Am Antibiotics, Dava Pharms Inc, Mylan, Purepac Pharm, Aurobindo Pharma, Hikma Pharms, Ivax Sub Teva Pharms, and Sandoz, and is included in thirteen NDAs. It is available from twenty-three suppliers. Additional details are available on the PENICILLIN V POTASSIUM profile page.
The generic ingredient in PENICILLIN V POTASSIUM is penicillin v potassium. There are ninety drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the penicillin v potassium profile page.
The generic ingredient in PENICILLIN V POTASSIUM is penicillin v potassium. There are ninety drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the penicillin v potassium profile page.
Summary for 062936
| Tradename: | PENICILLIN V POTASSIUM |
| Applicant: | Dava Pharms Inc |
| Ingredient: | penicillin v potassium |
| Patents: | 0 |
| Therapeutic Class: | Antibacterials |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 062936
| Ingredient-type | Penicillins |
Suppliers and Packaging for NDA: 062936
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PENICILLIN V POTASSIUM | penicillin v potassium | TABLET;ORAL | 062936 | ANDA | Liberty Pharmaceuticals, Inc. | 0440-2055 | N | 0440-2055-40 |
| PENICILLIN V POTASSIUM | penicillin v potassium | TABLET;ORAL | 062936 | ANDA | Liberty Pharmaceuticals, Inc. | 0440-8055 | N | 0440-8055-40 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Nov 25, 1988 | TE: | AB | RLD: | No | ||||
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