Details for New Drug Application (NDA): 218853
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NDA 218853 describes SERTRALINE HYDROCHLORIDE, which is a drug marketed by Almatica, Zenara, Aurobindo Pharma, Ranbaxy Labs Ltd, Strides Pharma, Accord Hlthcare, Appco, Ascent Pharms Inc, Chartwell Molecular, Granules, Heritage Pharma Avet, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan Pharms Inc, Oxford Pharms, Pharmaco, Pharmobedient, Quagen, Reyoung, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Torrent Pharms, Tp Anda Holdings, and Zydus, and is included in thirty-two NDAs. It is available from forty-one suppliers. Additional details are available on the SERTRALINE HYDROCHLORIDE profile page.
The generic ingredient in SERTRALINE HYDROCHLORIDE is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
The generic ingredient in SERTRALINE HYDROCHLORIDE is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
Summary for 218853
| Tradename: | SERTRALINE HYDROCHLORIDE |
| Applicant: | Zenara |
| Ingredient: | sertraline hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 218853
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 218853
Suppliers and Packaging for NDA: 218853
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SERTRALINE HYDROCHLORIDE | sertraline hydrochloride | CAPSULE;ORAL | 218853 | ANDA | Cipla USA Inc. | 69097-438 | 69097-438-02 | 30 CAPSULE in 1 BOTTLE (69097-438-02) |
| SERTRALINE HYDROCHLORIDE | sertraline hydrochloride | CAPSULE;ORAL | 218853 | ANDA | Cipla USA Inc. | 69097-451 | 69097-451-02 | 30 CAPSULE in 1 BOTTLE (69097-451-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Jul 16, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jan 18, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Jul 16, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jan 18, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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