Details for New Drug Application (NDA): 083312
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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. Two suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 083312
Tradename: | PROMETHAZINE HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | promethazine hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 083312
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | INJECTABLE;INJECTION | 083312 | ANDA | Henry Schein, Inc. | 0404-9940 | 0404-9940-01 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9940-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | INJECTABLE;INJECTION | 083312 | ANDA | Henry Schein, Inc. | 0404-9941 | 0404-9941-01 | 1 AMPULE in 1 BAG (0404-9941-01) / 1 mL in 1 AMPULE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes |
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