Details for New Drug Application (NDA): 071443
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NDA 071443 describes PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Fosun Pharma, Ivax Sub Teva Pharms, Mylan, Par Pharm, Sun Pharm Industries, and Watson Labs, and is included in thirty-five NDAs. It is available from one supplier. Additional details are available on the PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE profile page.
The generic ingredient in PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE 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 AND AMITRIPTYLINE HYDROCHLORIDE 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 071443
| Tradename: | PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE |
| Applicant: | Mylan |
| Ingredient: | amitriptyline hydrochloride; perphenazine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 071443
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride; perphenazine | TABLET;ORAL | 071443 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0042 | 0378-0042-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0042-01) |
| PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride; perphenazine | TABLET;ORAL | 071443 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0073 | 0378-0073-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0073-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG;4MG | ||||
| Approval Date: | Nov 10, 1988 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;2MG | ||||
| Approval Date: | Nov 10, 1988 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;4MG | ||||
| Approval Date: | Nov 10, 1988 | TE: | RLD: | No | |||||
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