Details for New Drug Application (NDA): 074878
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NDA 074878 describes PENTOXIFYLLINE, which is a drug marketed by Ani Pharms, Apotex, Heritage, Impax Labs, Pliva, Rising, and Valeant Pharms, and is included in nine NDAs. It is available from nine suppliers. Additional details are available on the PENTOXIFYLLINE profile page.
The generic ingredient in PENTOXIFYLLINE is pentoxifylline. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the pentoxifylline profile page.
The generic ingredient in PENTOXIFYLLINE is pentoxifylline. There are fourteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the pentoxifylline profile page.
Summary for 074878
| Tradename: | PENTOXIFYLLINE |
| Applicant: | Ani Pharms |
| Ingredient: | pentoxifylline |
| Patents: | 0 |
Pharmacology for NDA: 074878
| Physiological Effect | Hematologic Activity Alteration |
Medical Subject Heading (MeSH) Categories for 074878
Suppliers and Packaging for NDA: 074878
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PENTOXIFYLLINE | pentoxifylline | TABLET, EXTENDED RELEASE;ORAL | 074878 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8511 | 0615-8511-39 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8511-39) |
| PENTOXIFYLLINE | pentoxifylline | TABLET, EXTENDED RELEASE;ORAL | 074878 | ANDA | ANI Pharmaceuticals, Inc. | 70954-668 | 70954-668-10 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70954-668-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 400MG | ||||
| Approval Date: | Jul 9, 1997 | TE: | AB | RLD: | No | ||||
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