Details for New Drug Application (NDA): 040650
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NDA 040650 describes PROMETHAZINE WITH CODEINE, which is a drug marketed by Pharm Assoc and is included in one NDA. It is available from one supplier. Additional details are available on the PROMETHAZINE WITH CODEINE profile page.
The generic ingredient in PROMETHAZINE WITH CODEINE is codeine phosphate; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the codeine phosphate; promethazine hydrochloride profile page.
The generic ingredient in PROMETHAZINE WITH CODEINE is codeine phosphate; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the codeine phosphate; promethazine hydrochloride profile page.
Summary for 040650
| Tradename: | PROMETHAZINE WITH CODEINE |
| Applicant: | Pharm Assoc |
| Ingredient: | codeine phosphate; promethazine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 040650
| Mechanism of Action | Full Opioid Agonists |
Suppliers and Packaging for NDA: 040650
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE WITH CODEINE | codeine phosphate; promethazine hydrochloride | SYRUP;ORAL | 040650 | ANDA | Proficient Rx LP | 63187-271 | 63187-271-04 | 4 mL in 1 BOTTLE (63187-271-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 10MG/5ML;6.25MG/5ML | ||||
| Approval Date: | Jan 31, 2006 | TE: | AA | RLD: | No | ||||
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