DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 040712
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 040712
Tradename: | PROMETHAZINE HYDROCHLORIDE |
Applicant: | Kvk Tech |
Ingredient: | promethazine hydrochloride |
Patents: | 0 |
Therapeutic Class: | Antiemetics Respiratory Tract Agents |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040712
Ingredient-type | Phenothiazines |
Medical Subject Heading (MeSH) Categories for 040712
Suppliers and Packaging for NDA: 040712
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 040712 | ANDA | Liberty Pharmaceuticals, Inc. | 0440-8195 | N | 0440-8195-12 |
PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 040712 | ANDA | Major Pharmaceuticals | 0904-5840 | N | 0904-5840-61 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Jul 31, 2006 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
Approval Date: | May 4, 2007 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
Approval Date: | Jul 31, 2006 | TE: | AB | RLD: | No |
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