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Details for New Drug Application (NDA): 040712
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NDA 040712 describes PROMETHAZINE HYDROCHLORIDE, which is a drug marketed by Abbott, Akorn, Am Regent, Bedford Labs, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, West-ward Pharms Int, Wockhardt, Xgen Pharms, Able, Cosette, Padagis Israel, Taro, Watson Labs Inc, Amneal Pharms, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Whiteworth Town Plsn, Amneal Pharms Ny, Impax Labs, Invatech, 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, and Ani Pharms, and is included in eighty-nine NDAs. It is available from fifty 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 |
| Formulation / Manufacturing: | see details |
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 | KVK-Tech, Inc. | 10702-002 | 10702-002-01 | 100 TABLET in 1 BOTTLE (10702-002-01) |
| PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 040712 | ANDA | KVK-Tech, Inc. | 10702-002 | 10702-002-10 | 1000 TABLET in 1 BOTTLE (10702-002-10) |
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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