Details for New Drug Application (NDA): 040863
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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 040863
Tradename: | PROMETHAZINE HYDROCHLORIDE |
Applicant: | Sun Pharm Inds Inc |
Ingredient: | promethazine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 040863
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 040863 | ANDA | Proficient Rx LP | 63187-038 | 63187-038-10 | 10 TABLET in 1 BOTTLE (63187-038-10) |
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 040863 | ANDA | Proficient Rx LP | 63187-038 | 63187-038-12 | 12 TABLET in 1 BOTTLE (63187-038-12) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | Dec 30, 2008 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Dec 30, 2008 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Dec 30, 2008 | TE: | RLD: | No |
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