Details for New Drug Application (NDA): 074069
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NDA 074069 describes AZATHIOPRINE, which is a drug marketed by Alkem Labs Ltd, Amneal, Rising, Zydus Pharms Usa, and Hikma, and is included in five NDAs. It is available from nine suppliers. Additional details are available on the AZATHIOPRINE profile page.
The generic ingredient in AZATHIOPRINE 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 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 074069
| Tradename: | AZATHIOPRINE |
| Applicant: | Amneal |
| Ingredient: | azathioprine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074069
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 074069
Suppliers and Packaging for NDA: 074069
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZATHIOPRINE | azathioprine | TABLET;ORAL | 074069 | ANDA | AvKARE | 42291-063 | 42291-063-01 | 100 TABLET in 1 BOTTLE (42291-063-01) |
| AZATHIOPRINE | azathioprine | TABLET;ORAL | 074069 | ANDA | AvKARE | 42291-071 | 42291-071-01 | 100 TABLET in 1 BOTTLE (42291-071-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Feb 16, 1996 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
| Approval Date: | Nov 2, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Nov 2, 2021 | TE: | AB | RLD: | No | ||||
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