Details for New Drug Application (NDA): 040268
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NDA 040268 describes PROCOMP, which is a drug marketed by Jubilant Cadista and is included in one NDA. It is available from twelve suppliers. Additional details are available on the PROCOMP profile page.
The generic ingredient in PROCOMP is prochlorperazine maleate. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the prochlorperazine maleate profile page.
The generic ingredient in PROCOMP is prochlorperazine maleate. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the prochlorperazine maleate profile page.
Summary for 040268
| Tradename: | PROCOMP |
| Applicant: | Jubilant Cadista |
| Ingredient: | prochlorperazine maleate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 040268
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROCOMP | prochlorperazine maleate | TABLET;ORAL | 040268 | ANDA | QPharma Inc | 42708-103 | 42708-103-12 | 12 TABLET in 1 BOTTLE (42708-103-12) |
| PROCOMP | prochlorperazine maleate | TABLET;ORAL | 040268 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-742 | 43063-742-06 | 6 TABLET in 1 BOTTLE, PLASTIC (43063-742-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Feb 27, 1998 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Feb 27, 1998 | TE: | AB | RLD: | No | ||||
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