Details for New Drug Application (NDA): 091179
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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 091179
Tradename: | PROMETHAZINE HYDROCHLORIDE |
Applicant: | Amneal Pharms Ny |
Ingredient: | promethazine hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 091179
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 091179 | ANDA | Major Pharmaceuticals | 0904-7304 | 0904-7304-61 | 100 BLISTER PACK in 1 CARTON (0904-7304-61) / 1 TABLET in 1 BLISTER PACK |
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 091179 | ANDA | Marlex Pharmaceuticals Inc | 10135-495 | 10135-495-01 | 100 TABLET in 1 BOTTLE (10135-495-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | Dec 13, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Dec 13, 2010 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Dec 13, 2010 | TE: | AB | RLD: | No |
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