Details for New Drug Application (NDA): 075191
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NDA 075191 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 075191
| Tradename: | PENTOXIFYLLINE |
| Applicant: | Apotex |
| Ingredient: | pentoxifylline |
| Patents: | 0 |
Pharmacology for NDA: 075191
| Physiological Effect | Hematologic Activity Alteration |
Medical Subject Heading (MeSH) Categories for 075191
Suppliers and Packaging for NDA: 075191
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PENTOXIFYLLINE | pentoxifylline | TABLET, EXTENDED RELEASE;ORAL | 075191 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8305 | 0615-8305-39 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8305-39) |
| PENTOXIFYLLINE | pentoxifylline | TABLET, EXTENDED RELEASE;ORAL | 075191 | ANDA | Major Pharmaceuticals | 0904-5448 | 0904-5448-61 | 100 BLISTER PACK in 1 CARTON (0904-5448-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 400MG | ||||
| Approval Date: | Jun 9, 1999 | TE: | AB | RLD: | No | ||||
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