Details for New Drug Application (NDA): 216446
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The generic ingredient in PROMETHAZINE HYDROCHLORIDE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 216446
Tradename: | PROMETHAZINE HYDROCHLORIDE |
Applicant: | Annora Pharma |
Ingredient: | promethazine hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 216446
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SUPPOSITORY;RECTAL | 216446 | ANDA | Camber Pharmaceuticals, Inc. | 31722-040 | 31722-040-31 | 2 BLISTER PACK in 1 CARTON (31722-040-31) / 6 SUPPOSITORY in 1 BLISTER PACK |
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SUPPOSITORY;RECTAL | 216446 | ANDA | Camber Pharmaceuticals, Inc. | 31722-041 | 31722-041-31 | 2 BLISTER PACK in 1 CARTON (31722-041-31) / 6 SUPPOSITORY in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUPPOSITORY;RECTAL | Strength | 12.5MG | ||||
Approval Date: | Nov 2, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SUPPOSITORY;RECTAL | Strength | 25MG | ||||
Approval Date: | Nov 2, 2022 | TE: | AB | RLD: | No |
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