Details for New Drug Application (NDA): 075252
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NDA 075252 describes AZASAN, which is a drug marketed by Aaipharma Llc and is included in one NDA. It is available from four suppliers. Additional details are available on the AZASAN profile page.
The generic ingredient in AZASAN is azathioprine. There are sixteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the azathioprine profile page.
The generic ingredient in AZASAN is azathioprine. There are sixteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the azathioprine profile page.
Summary for 075252
| Tradename: | AZASAN |
| Applicant: | Aaipharma Llc |
| Ingredient: | azathioprine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075252
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 075252
Suppliers and Packaging for NDA: 075252
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZASAN | azathioprine | TABLET;ORAL | 075252 | ANDA | Golden State Medical Supply, Inc. | 51407-182 | 51407-182-01 | 100 TABLET in 1 BOTTLE (51407-182-01) |
| AZASAN | azathioprine | TABLET;ORAL | 075252 | ANDA | Salix Pharmaceuticals | 65649-231 | 65649-231-41 | 100 TABLET in 1 BOTTLE (65649-231-41) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jun 7, 1999 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Feb 3, 2003 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
| Approval Date: | Feb 3, 2003 | TE: | AB | RLD: | No | ||||
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