Details for New Drug Application (NDA): 075028
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NDA 075028 describes PENTOXIFYLLINE, which is a drug marketed by Ani Pharms, Apotex, Heritage Pharms, 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 075028
| Tradename: | PENTOXIFYLLINE |
| Applicant: | Valeant Pharms |
| Ingredient: | pentoxifylline |
| Patents: | 0 |
Pharmacology for NDA: 075028
| Physiological Effect | Hematologic Activity Alteration |
Medical Subject Heading (MeSH) Categories for 075028
Suppliers and Packaging for NDA: 075028
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PENTOXIFYLLINE | pentoxifylline | TABLET, EXTENDED RELEASE;ORAL | 075028 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-4532 | 68071-4532-9 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-4532-9) |
| PENTOXIFYLLINE | pentoxifylline | TABLET, EXTENDED RELEASE;ORAL | 075028 | ANDA | Oceanside Pharmaceuticals | 68682-101 | 68682-101-10 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-101-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 400MG | ||||
| Approval Date: | Jul 20, 1998 | TE: | AB | RLD: | No | ||||
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