Details for New Drug Application (NDA): 215615
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NDA 215615 describes METHAZOLAMIDE, which is a drug marketed by Ani Pharms, Applied Anal, Athem, Bausch And Lomb Inc, Mikart, Sandoz, and Tagi, and is included in seven NDAs. It is available from eleven suppliers. Additional details are available on the METHAZOLAMIDE profile page.
The generic ingredient in METHAZOLAMIDE is methazolamide. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the methazolamide profile page.
The generic ingredient in METHAZOLAMIDE is methazolamide. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the methazolamide profile page.
Summary for 215615
| Tradename: | METHAZOLAMIDE |
| Applicant: | Tagi |
| Ingredient: | methazolamide |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 215615
Suppliers and Packaging for NDA: 215615
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METHAZOLAMIDE | methazolamide | TABLET;ORAL | 215615 | ANDA | TAGI Pharma, Inc. | 51224-024 | 51224-024-50 | 100 TABLET in 1 BOTTLE (51224-024-50) |
| METHAZOLAMIDE | methazolamide | TABLET;ORAL | 215615 | ANDA | TAGI Pharma, Inc. | 51224-124 | 51224-124-50 | 100 TABLET in 1 BOTTLE (51224-124-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Oct 18, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Oct 18, 2022 | TE: | AB | RLD: | No | ||||
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