Details for New Drug Application (NDA): 216595
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The generic ingredient in PROCHLORPERAZINE MALEATE is prochlorperazine maleate. There are twenty-one drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the prochlorperazine maleate profile page.
Summary for 216595
Tradename: | PROCHLORPERAZINE MALEATE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | prochlorperazine maleate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 216595
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROCHLORPERAZINE MALEATE | prochlorperazine maleate | TABLET;ORAL | 216595 | ANDA | GLENMARK PHARMACEUTICALS INC., USA | 68462-889 | 68462-889-01 | 100 TABLET in 1 BOTTLE (68462-889-01) |
PROCHLORPERAZINE MALEATE | prochlorperazine maleate | TABLET;ORAL | 216595 | ANDA | GLENMARK PHARMACEUTICALS INC., USA | 68462-889 | 68462-889-10 | 1000 TABLET in 1 BOTTLE (68462-889-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Mar 17, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Mar 17, 2023 | TE: | AB | RLD: | No |
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