Details for New Drug Application (NDA): 213441
✉ Email this page to a colleague
NDA 213441 describes NORTRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Rising, Taro, Teva, Zydus Lifesciences, 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 213441
| Tradename: | NORTRIPTYLINE HYDROCHLORIDE |
| Applicant: | Zydus Lifesciences |
| Ingredient: | nortriptyline hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213441
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORTRIPTYLINE HYDROCHLORIDE | nortriptyline hydrochloride | CAPSULE;ORAL | 213441 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1153 | 70710-1153-1 | 100 CAPSULE in 1 BOTTLE (70710-1153-1) |
| NORTRIPTYLINE HYDROCHLORIDE | nortriptyline hydrochloride | CAPSULE;ORAL | 213441 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1153 | 70710-1153-3 | 30 CAPSULE in 1 BOTTLE (70710-1153-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Feb 24, 2021 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Feb 24, 2021 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Feb 24, 2021 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
