Details for New Drug Application (NDA): 202147
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NDA 202147 describes COSYNTROPIN, which is a drug marketed by Mylan Institutional and Sandoz and is included in three NDAs. It is available from three suppliers. Additional details are available on the COSYNTROPIN profile page.
The generic ingredient in COSYNTROPIN is cosyntropin. There are two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the cosyntropin profile page.
The generic ingredient in COSYNTROPIN is cosyntropin. There are two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the cosyntropin profile page.
Summary for 202147
| Tradename: | COSYNTROPIN |
| Applicant: | Sandoz |
| Ingredient: | cosyntropin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202147
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COSYNTROPIN | cosyntropin | INJECTABLE;INJECTION | 202147 | ANDA | Sandoz Inc | 0781-3440 | 0781-3440-95 | 10 VIAL in 1 CARTON (0781-3440-95) / 1 mL in 1 VIAL (0781-3440-71) |
| COSYNTROPIN | cosyntropin | INJECTABLE;INJECTION | 202147 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1567 | 51662-1567-1 | 1 mL in 1 VIAL (51662-1567-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25MG/VIAL | ||||
| Approval Date: | Jun 29, 2012 | TE: | AP | RLD: | No | ||||
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