Details for New Drug Application (NDA): 091179
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NDA 091179 describes PROMETHAZINE HYDROCHLORIDE, which is a drug marketed by Abbott, Am Regent, Bedford Labs, Epic Pharma Llc, Hikma, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, Wockhardt, Xgen Pharms, Able, Annora Pharma, Cosette, Padagis Israel, Taro, Watson Labs Inc, Amneal Pharms, Chartwell Rx, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Whiteworth Town Plsn, Amneal Pharms Ny, Aurobindo Pharma Usa, Chartwell Molecular, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, 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 ninety NDAs. It is available from forty-seven 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. Two 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. Two suppliers are listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 091179
| Tradename: | PROMETHAZINE HYDROCHLORIDE |
| Applicant: | Amneal Pharms Ny |
| Ingredient: | promethazine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091179
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 091179 | ANDA | Major Pharmaceuticals | 0904-7304 | 0904-7304-61 | 100 BLISTER PACK in 1 CARTON (0904-7304-61) / 1 TABLET in 1 BLISTER PACK |
| PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | TABLET;ORAL | 091179 | ANDA | Marlex Pharmaceuticals Inc | 10135-495 | 10135-495-01 | 100 TABLET in 1 BOTTLE (10135-495-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Dec 13, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Dec 13, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Dec 13, 2010 | TE: | AB | RLD: | No | ||||
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