Details for New Drug Application (NDA): 214321
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The generic ingredient in POSACONAZOLE is posaconazole. There are twenty-one drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
Summary for 214321
Tradename: | POSACONAZOLE |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | posaconazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 214321
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POSACONAZOLE | posaconazole | TABLET, DELAYED RELEASE;ORAL | 214321 | ANDA | NorthStar RxLLC | 16714-535 | 16714-535-01 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (16714-535-01) |
POSACONAZOLE | posaconazole | TABLET, DELAYED RELEASE;ORAL | 214321 | ANDA | Camber Pharmaceuticals, Inc. | 31722-677 | 31722-677-60 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (31722-677-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | Dec 8, 2022 | TE: | AB | RLD: | No |
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