Details for New Drug Application (NDA): 087165
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NDA 087165 describes PROMETHEGAN, which is a drug marketed by Cosette and is included in one NDA. It is available from one supplier. Additional details are available on the PROMETHEGAN profile page.
The generic ingredient in PROMETHEGAN is promethazine hydrochloride. There are twelve drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.
The generic ingredient in PROMETHEGAN is promethazine hydrochloride. There are twelve drug master file entries for this compound. Forty-five 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 |
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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