Details for New Drug Application (NDA): 040500
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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 040500
Tradename: | PROMETHAZINE HYDROCHLORIDE |
Applicant: | Padagis Israel |
Ingredient: | promethazine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 040500
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SUPPOSITORY;RECTAL | 040500 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-060 | 43063-060-02 | 2 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-02) |
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | SUPPOSITORY;RECTAL | 040500 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-060 | 43063-060-04 | 4 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUPPOSITORY;RECTAL | Strength | 12.5MG | ||||
Approval Date: | Jun 30, 2003 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SUPPOSITORY;RECTAL | Strength | 25MG | ||||
Approval Date: | Jun 30, 2003 | TE: | AB | RLD: | No |
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