Details for New Drug Application (NDA): 074132
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NDA 074132 describes NORTRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Rising, Taro, Teva, Zydus, Pharm Assoc, and Rubicon, and is included in eleven NDAs. It is available from twenty-seven suppliers. Additional details are available on the NORTRIPTYLINE HYDROCHLORIDE profile page.
The generic ingredient in NORTRIPTYLINE HYDROCHLORIDE is nortriptyline hydrochloride. There are twelve drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the nortriptyline hydrochloride profile page.
The generic ingredient in NORTRIPTYLINE HYDROCHLORIDE is nortriptyline hydrochloride. There are twelve drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the nortriptyline hydrochloride profile page.
Summary for 074132
| Tradename: | NORTRIPTYLINE HYDROCHLORIDE |
| Applicant: | Teva |
| Ingredient: | nortriptyline hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 074132
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORTRIPTYLINE HYDROCHLORIDE | nortriptyline hydrochloride | CAPSULE;ORAL | 074132 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-0810 | 0093-0810-01 | 100 CAPSULE in 1 BOTTLE (0093-0810-01) |
| NORTRIPTYLINE HYDROCHLORIDE | nortriptyline hydrochloride | CAPSULE;ORAL | 074132 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-0810 | 0093-0810-05 | 500 CAPSULE in 1 BOTTLE (0093-0810-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Mar 27, 1995 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Mar 27, 1995 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Mar 27, 1995 | TE: | AB | RLD: | No | ||||
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