Details for New Drug Application (NDA): 216598
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NDA 216598 describes PROCHLORPERAZINE MALEATE, which is a drug marketed by Ajanta Pharma Ltd, Amneal, Bionpharma, Chartwell Rx, Duramed Pharms Barr, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Leading, Norvium Bioscience, Novitium Pharma, Teva Pharms, and Zydus Lifesciences, and is included in fifteen NDAs. It is available from seventeen suppliers. Additional details are available on the PROCHLORPERAZINE MALEATE profile page.
The generic ingredient in PROCHLORPERAZINE MALEATE is prochlorperazine maleate. 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 prochlorperazine maleate profile page.
The generic ingredient in PROCHLORPERAZINE MALEATE is prochlorperazine maleate. 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 prochlorperazine maleate profile page.
Summary for 216598
| Tradename: | PROCHLORPERAZINE MALEATE |
| Applicant: | Amneal |
| Ingredient: | prochlorperazine maleate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216598
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROCHLORPERAZINE MALEATE | prochlorperazine maleate | TABLET;ORAL | 216598 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-2038 | 60219-2038-1 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-2038-1) |
| PROCHLORPERAZINE MALEATE | prochlorperazine maleate | TABLET;ORAL | 216598 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-2038 | 60219-2038-7 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-2038-7) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Apr 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: | Apr 17, 2023 | TE: | AB | RLD: | No | ||||
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