Details for New Drug Application (NDA): 090462
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NDA 090462 describes PROTRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Epic Pharma Llc, Hikma, and Sigmapharm Labs Llc, and is included in three NDAs. It is available from three suppliers. Additional details are available on the PROTRIPTYLINE HYDROCHLORIDE profile page.
The generic ingredient in PROTRIPTYLINE HYDROCHLORIDE is protriptyline hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the protriptyline hydrochloride profile page.
The generic ingredient in PROTRIPTYLINE HYDROCHLORIDE is protriptyline hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the protriptyline hydrochloride profile page.
Summary for 090462
| Tradename: | PROTRIPTYLINE HYDROCHLORIDE |
| Applicant: | Sigmapharm Labs Llc |
| Ingredient: | protriptyline hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 090462
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROTRIPTYLINE HYDROCHLORIDE | protriptyline hydrochloride | TABLET;ORAL | 090462 | ANDA | Sigmapharm Laboratories, LLC | 42794-004 | 42794-004-02 | 100 TABLET, FILM COATED in 1 BOTTLE (42794-004-02) |
| PROTRIPTYLINE HYDROCHLORIDE | protriptyline hydrochloride | TABLET;ORAL | 090462 | ANDA | Sigmapharm Laboratories, LLC | 42794-007 | 42794-007-02 | 100 TABLET, FILM COATED in 1 BOTTLE (42794-007-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | May 3, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 3, 2010 | TE: | AB | RLD: | No | ||||
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