Details for New Drug Application (NDA): 207582
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NDA 207582 describes PERPHENAZINE, which is a drug marketed by Pharm Assoc, Ani Pharms, Appco, Endo Operations, Macleods Pharms Ltd, Mylan, Rising, Sandoz, Watson Labs Inc, Wilshire Pharms Inc, Zydus Pharms, Chartwell Rx, Fosun Pharma, Ivax Sub Teva Pharms, Par Pharm, Sun Pharm Industries, and Watson Labs, and is included in forty-nine NDAs. It is available from sixteen suppliers. Additional details are available on the PERPHENAZINE profile page.
The generic ingredient in PERPHENAZINE is amitriptyline hydrochloride; perphenazine. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amitriptyline hydrochloride; perphenazine profile page.
The generic ingredient in PERPHENAZINE is amitriptyline hydrochloride; perphenazine. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amitriptyline hydrochloride; perphenazine profile page.
Summary for 207582
| Tradename: | PERPHENAZINE |
| Applicant: | Watson Labs Inc |
| Ingredient: | perphenazine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207582
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PERPHENAZINE | perphenazine | TABLET;ORAL | 207582 | ANDA | Actavis Pharma, Inc. | 0591-4101 | 0591-4101-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0591-4101-01) |
| PERPHENAZINE | perphenazine | TABLET;ORAL | 207582 | ANDA | Actavis Pharma, Inc. | 0591-4102 | 0591-4102-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0591-4102-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Oct 17, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | Oct 17, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
| Approval Date: | Oct 17, 2016 | TE: | AB | RLD: | No | ||||
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