Details for New Drug Application (NDA): 074419
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NDA 074419 describes AZATHIOPRINE SODIUM, which is a drug marketed by Hikma and is included in one NDA. It is available from one supplier. Additional details are available on the AZATHIOPRINE SODIUM profile page.
The generic ingredient in AZATHIOPRINE SODIUM is azathioprine sodium. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the azathioprine sodium profile page.
The generic ingredient in AZATHIOPRINE SODIUM is azathioprine sodium. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the azathioprine sodium profile page.
Summary for 074419
| Tradename: | AZATHIOPRINE SODIUM |
| Applicant: | Hikma |
| Ingredient: | azathioprine sodium |
| Patents: | 0 |
Pharmacology for NDA: 074419
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 074419
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZATHIOPRINE SODIUM | azathioprine sodium | INJECTABLE;INJECTION | 074419 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9566 | 0143-9566-01 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9566-01) / 10 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/VIAL | ||||
| Approval Date: | Mar 31, 1995 | TE: | RLD: | No | |||||
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