Details for New Drug Application (NDA): 087953
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The generic ingredient in PROMETHAZINE PLAIN is promethazine hydrochloride. There are twelve drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the promethazine hydrochloride profile page.
Summary for 087953
Tradename: | PROMETHAZINE PLAIN |
Applicant: | Wockhardt Bio Ag |
Ingredient: | promethazine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 087953
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE PLAIN | promethazine hydrochloride | SYRUP;ORAL | 087953 | ANDA | Wockhardt USA LLC. | 64679-608 | 64679-608-16 | 473 mL in 1 BOTTLE, PLASTIC (64679-608-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 6.25MG/5ML | ||||
Approval Date: | Nov 15, 1982 | TE: | AA | RLD: | Yes |
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