Details for New Drug Application (NDA): 212500
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The generic ingredient in POSACONAZOLE is posaconazole. There are twenty-one drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
Summary for 212500
Tradename: | POSACONAZOLE |
Applicant: | Dr Reddys |
Ingredient: | posaconazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 212500
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POSACONAZOLE | posaconazole | TABLET, DELAYED RELEASE;ORAL | 212500 | ANDA | Dr.Reddys Laboratories Inc | 43598-470 | 43598-470-60 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (43598-470-60) |
POSACONAZOLE | posaconazole | TABLET, DELAYED RELEASE;ORAL | 212500 | ANDA | AvPAK | 50268-683 | 50268-683-12 | 20 BLISTER PACK in 1 BOX (50268-683-12) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-683-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 100MG | ||||
Approval Date: | Apr 7, 2022 | TE: | AB | RLD: | No |
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