DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 040712
NDA 040712 describes PROMETHAZINE HYDROCHLORIDE, which is a drug marketed by Abbott, Akorn, Bedford Labs, Hospira, Luitpold, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, West-ward Pharms Int, Wockhardt, X-gen Pharms, Able, G And W Labs, Perrigo New York, Taro, Watson Labs Inc, Amneal Pharms, Hi Tech Pharma, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Tris Pharma Inc, Vintage, Whiteworth Town Plsn, Amneal Pharms Ny, Heritage Pharma, Impax Labs, Ivax Sub Teva Pharms, Kvk Tech, Lannett, Mylan, Prinston Inc, Pvt Form, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Wockhardt Bio Ag, Ani Pharms, and Hi-tech Pharma Co, and is included in eighty-seven NDAs. It is available from fifty-eight suppliers. Additional details are available on the PROMETHAZINE HYDROCHLORIDE profile page.
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.
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 | ||||
Complete Access Available with Subscription
