Details for New Drug Application (NDA): 091675
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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 091675
Tradename: | PROMETHAZINE HYDROCHLORIDE |
Applicant: | Tris Pharma Inc |
Ingredient: | promethazine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 091675
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SYRUP;ORAL | 091675 | ANDA | ATLANTIC BIOLOGICALS CORP | 17856-0059 | 17856-0059-1 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0059-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0059-2) |
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SYRUP;ORAL | 091675 | ANDA | Tris Pharma Inc | 27808-051 | 27808-051-02 | 473 mL in 1 BOTTLE (27808-051-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 6.25MG/5ML | ||||
Approval Date: | Jun 28, 2012 | TE: | AA | RLD: | No |
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