Details for New Drug Application (NDA): 213368
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NDA 213368 describes CHLORPROMAZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Genus, Pharm Assoc, Wockhardt, Abraxis Pharm, Deva Hlding, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hikma, Marsam Pharms Llc, Watson Labs, Wyeth Ayerst, Zydus Pharms, Alpharma Us Pharms, Abbott, Alembic, Amneal Pharms Co, Appco, Chartwell Rx, Cycle, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Kv Pharm, Lannett Co Inc, Lederle, Lupin, MSN, Purepac Pharm, Pvt Form, Sun Pharm, Teva Pharms, Upsher Smith Labs, Vangard, West Ward, and Zydus Lifesciences, and is included in seventy NDAs. It is available from twenty-nine suppliers. Additional details are available on the CHLORPROMAZINE HYDROCHLORIDE profile page.
The generic ingredient in CHLORPROMAZINE HYDROCHLORIDE is chlorpromazine hydrochloride. There are twenty-four drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the chlorpromazine hydrochloride profile page.
The generic ingredient in CHLORPROMAZINE HYDROCHLORIDE is chlorpromazine hydrochloride. There are twenty-four drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the chlorpromazine hydrochloride profile page.
Summary for 213368
| Tradename: | CHLORPROMAZINE HYDROCHLORIDE |
| Applicant: | Zydus Lifesciences |
| Ingredient: | chlorpromazine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213368
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLORPROMAZINE HYDROCHLORIDE | chlorpromazine hydrochloride | TABLET;ORAL | 213368 | ANDA | Major Pharmaceuticals | 0904-7129 | 0904-7129-61 | 100 BLISTER PACK in 1 CARTON (0904-7129-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| CHLORPROMAZINE HYDROCHLORIDE | chlorpromazine hydrochloride | TABLET;ORAL | 213368 | ANDA | Major Pharmaceuticals | 0904-7130 | 0904-7130-06 | 50 BLISTER PACK in 1 CARTON (0904-7130-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jan 17, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Jan 17, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jan 17, 2020 | TE: | AB | RLD: | No | ||||
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