Details for New Drug Application (NDA): 084176
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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. Three suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 084176
Tradename: | PROMETHAZINE HYDROCHLORIDE |
Applicant: | Sandoz |
Ingredient: | promethazine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 084176
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 084176 | ANDA | Sandoz Inc | 0781-1830 | 0781-1830-01 | 100 TABLET in 1 BOTTLE (0781-1830-01) |
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 084176 | ANDA | Sandoz Inc | 0781-1830 | 0781-1830-10 | 1000 TABLET in 1 BOTTLE (0781-1830-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | May 22, 2009 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
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