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-two 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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