Details for New Drug Application (NDA): 091437
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NDA 091437 describes TRIMETHOPRIM, which is a drug marketed by Dr Reddys Labs Sa, Novel Labs Inc, Novitium Pharma, Sun Pharm Industries, Teva, Watson Labs, Bausch And Lomb, Epic Pharma Llc, and Sandoz, and is included in ten NDAs. It is available from six suppliers. Additional details are available on the TRIMETHOPRIM profile page.
The generic ingredient in TRIMETHOPRIM is polymyxin b sulfate; trimethoprim sulfate. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate; trimethoprim sulfate profile page.
The generic ingredient in TRIMETHOPRIM is polymyxin b sulfate; trimethoprim sulfate. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate; trimethoprim sulfate profile page.
Summary for 091437
| Tradename: | TRIMETHOPRIM |
| Applicant: | Novel Labs Inc |
| Ingredient: | trimethoprim |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 091437
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIMETHOPRIM | trimethoprim | TABLET;ORAL | 091437 | ANDA | Novel Laboratories, Inc. | 40032-330 | 40032-330-24 | 100 TABLET in 1 BOTTLE (40032-330-24) |
| TRIMETHOPRIM | trimethoprim | TABLET;ORAL | 091437 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-330 | 43386-330-01 | 100 TABLET in 1 BOTTLE (43386-330-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jun 15, 2011 | TE: | AB | RLD: | No | ||||
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