Details for New Drug Application (NDA): 213626
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The generic ingredient in PROCHLORPERAZINE EDISYLATE is prochlorperazine edisylate. There are twenty-one drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the prochlorperazine edisylate profile page.
Summary for 213626
Tradename: | PROCHLORPERAZINE EDISYLATE |
Applicant: | Viwit Pharm |
Ingredient: | prochlorperazine edisylate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213626
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROCHLORPERAZINE EDISYLATE | prochlorperazine edisylate | INJECTABLE;INJECTION | 213626 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0351 | 0713-0351-09 | 10 VIAL in 1 PACKAGE (0713-0351-09) / 2 mL in 1 VIAL (0713-0351-02) |
PROCHLORPERAZINE EDISYLATE | prochlorperazine edisylate | INJECTABLE;INJECTION | 213626 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0351 | 0713-0351-25 | 25 VIAL in 1 PACKAGE (0713-0351-25) / 2 mL in 1 VIAL (0713-0351-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 5MG BASE/ML | ||||
Approval Date: | Sep 28, 2021 | TE: | AP | RLD: | No |
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