Details for New Drug Application (NDA): 216393
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NDA 216393 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, Sandoz, and Somerset Theraps Llc, and is included in eleven 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate; trimethoprim sulfate profile page.
Summary for 216393
| Tradename: | TRIMETHOPRIM |
| Applicant: | Novitium Pharma |
| Ingredient: | trimethoprim |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216393
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIMETHOPRIM | trimethoprim | TABLET;ORAL | 216393 | ANDA | Golden State Medical Supply, Inc. | 51407-738 | 51407-738-01 | 100 TABLET in 1 BOTTLE, PLASTIC (51407-738-01) |
| TRIMETHOPRIM | trimethoprim | TABLET;ORAL | 216393 | ANDA | Novitium Pharma LLC | 70954-541 | 70954-541-10 | 100 TABLET in 1 BOTTLE, PLASTIC (70954-541-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Oct 28, 2022 | TE: | AB | RLD: | No | ||||
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