Details for New Drug Application (NDA): 019839
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NDA 019839 describes ZOLOFT, which is a drug marketed by Viatris and is included in two NDAs. It is available from three suppliers. Additional details are available on the ZOLOFT profile page.
The generic ingredient in ZOLOFT is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
The generic ingredient in ZOLOFT is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
Summary for 019839
| Tradename: | ZOLOFT |
| Applicant: | Viatris |
| Ingredient: | sertraline hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019839
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 019839
Suppliers and Packaging for NDA: 019839
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839 | NDA | ROERIG | 0049-4900 | 0049-4900-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0049-4900-30) |
| ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839 | NDA | ROERIG | 0049-4900 | 0049-4900-41 | 100 BLISTER PACK in 1 CARTON (0049-4900-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Dec 30, 1991 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Dec 30, 1991 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 30, 1991 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 019839
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-005 | Mar 6, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-005 | Mar 6, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-003 | Dec 30, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-005 | Mar 6, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-003 | Dec 30, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-005 | Mar 6, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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