Details for New Drug Application (NDA): 087165
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The generic ingredient in PROMETHEGAN is promethazine hydrochloride. There are twelve drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.
Summary for 087165
Tradename: | PROMETHEGAN |
Applicant: | Cosette |
Ingredient: | promethazine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 087165
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMETHEGAN | promethazine hydrochloride | SUPPOSITORY;RECTAL | 087165 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0132 | 0713-0132-10 | 1000 SUPPOSITORY in 1 BOX (0713-0132-10) |
PROMETHEGAN | promethazine hydrochloride | SUPPOSITORY;RECTAL | 087165 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0132 | 0713-0132-12 | 12 SUPPOSITORY in 1 BOX (0713-0132-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUPPOSITORY;RECTAL | Strength | 50MG | ||||
Approval Date: | Aug 14, 1987 | TE: | RLD: | No |
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