Details for New Drug Application (NDA): 217731
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NDA 217731 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 217731
| Tradename: | NORTRIPTYLINE HYDROCHLORIDE |
| Applicant: | Rubicon |
| Ingredient: | nortriptyline hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217731
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORTRIPTYLINE HYDROCHLORIDE | nortriptyline hydrochloride | SOLUTION;ORAL | 217731 | ANDA | Advagen Pharma Ltd | 72888-157 | 72888-157-39 | 473 mL in 1 BOTTLE (72888-157-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 10MG BASE/5ML | ||||
| Approval Date: | Aug 15, 2023 | TE: | AA | RLD: | No | ||||
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