Details for New Drug Application (NDA): 040891
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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 040891
Tradename: | PROMETHAZINE HYDROCHLORIDE |
Applicant: | Nostrum Labs Inc |
Ingredient: | promethazine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 040891
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SYRUP;ORAL | 040891 | ANDA | Nostrum Laboratories, Inc. | 29033-500 | 29033-500-34 | 473 mL in 1 BOTTLE (29033-500-34) |
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SYRUP;ORAL | 040891 | ANDA | Proficient Rx LP | 63187-858 | 63187-858-04 | 118 mL in 1 BOTTLE (63187-858-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 6.25MG/5ML | ||||
Approval Date: | Mar 13, 2009 | TE: | AA | RLD: | No |
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