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 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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