Details for New Drug Application (NDA): 020990
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NDA 020990 describes ZOLOFT, which is a drug marketed by Viatris and is included in two NDAs. It is available from four 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. Fifty-one 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. Fifty-one suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
Summary for 020990
| Tradename: | ZOLOFT |
| Applicant: | Viatris |
| Ingredient: | sertraline hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 020990
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 020990
Suppliers and Packaging for NDA: 020990
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZOLOFT | sertraline hydrochloride | CONCENTRATE;ORAL | 020990 | NDA | ROERIG | 0049-0050 | 0049-0050-01 | 1 BOTTLE, DROPPER in 1 CARTON (0049-0050-01) / 60 mL in 1 BOTTLE, DROPPER |
| ZOLOFT | sertraline hydrochloride | CONCENTRATE;ORAL | 020990 | NDA | Viatris Specialty LLC | 58151-601 | 58151-601-35 | 1 BOTTLE, DROPPER in 1 CARTON (58151-601-35) / 60 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CONCENTRATE;ORAL | Strength | EQ 20MG BASE/ML | ||||
| Approval Date: | Dec 7, 1999 | TE: | AA | RLD: | Yes | ||||
Expired US Patents for NDA 020990
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris | ZOLOFT | sertraline hydrochloride | CONCENTRATE;ORAL | 020990-001 | Dec 7, 1999 | 4,536,518*PED | ⤷ Get Started Free |
| Viatris | ZOLOFT | sertraline hydrochloride | CONCENTRATE;ORAL | 020990-001 | Dec 7, 1999 | 5,789,449 | ⤷ Get Started Free |
| Viatris | ZOLOFT | sertraline hydrochloride | CONCENTRATE;ORAL | 020990-001 | Dec 7, 1999 | 6,727,283*PED | ⤷ Get Started Free |
| Viatris | ZOLOFT | sertraline hydrochloride | CONCENTRATE;ORAL | 020990-001 | Dec 7, 1999 | 7,067,555*PED | ⤷ Get Started Free |
| Viatris | ZOLOFT | sertraline hydrochloride | CONCENTRATE;ORAL | 020990-001 | Dec 7, 1999 | 5,744,501 | ⤷ Get Started Free |
| Viatris | ZOLOFT | sertraline hydrochloride | CONCENTRATE;ORAL | 020990-001 | Dec 7, 1999 | 4,940,731 | ⤷ Get Started Free |
| Viatris | ZOLOFT | sertraline hydrochloride | CONCENTRATE;ORAL | 020990-001 | Dec 7, 1999 | 5,248,699*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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