Details for New Drug Application (NDA): 065435
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NDA 065435 describes PENICILLIN V POTASSIUM, which is a drug marketed by Belcher Pharms, Chartwell Rx, Mylan, Purepac Pharm, Aurobindo Pharma, Hikma Pharms, Ivax Sub Teva Pharms, and Sandoz, and is included in thirteen NDAs. It is available from seventeen 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-two drug master file entries for this compound. Nineteen 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-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the penicillin v potassium profile page.
Summary for 065435
| Tradename: | PENICILLIN V POTASSIUM |
| Applicant: | Aurobindo Pharma |
| Ingredient: | penicillin v potassium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065435
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PENICILLIN V POTASSIUM | penicillin v potassium | TABLET;ORAL | 065435 | ANDA | NorthStar Rx LLC | 16714-234 | 16714-234-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-234-01) |
| PENICILLIN V POTASSIUM | penicillin v potassium | TABLET;ORAL | 065435 | ANDA | NorthStar Rx LLC | 16714-234 | 16714-234-02 | 1000 TABLET, FILM COATED in 1 BOTTLE (16714-234-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Apr 29, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Apr 29, 2008 | TE: | AB | RLD: | No | ||||
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