Details for New Drug Application (NDA): 216483
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NDA 216483 describes PIVYA, which is a drug marketed by Alembic Therap and is included in one NDA. It is available from one supplier. Additional details are available on the PIVYA profile page.
The generic ingredient in PIVYA is pivmecillinam hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pivmecillinam hydrochloride profile page.
The generic ingredient in PIVYA is pivmecillinam hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pivmecillinam hydrochloride profile page.
Summary for 216483
| Tradename: | PIVYA |
| Applicant: | Alembic Therap |
| Ingredient: | pivmecillinam hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216483
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIVYA | pivmecillinam hydrochloride | TABLET;ORAL | 216483 | NDA | Alembic Pharmaceuticals Inc. | 62332-966 | 62332-966-09 | 1 BLISTER PACK in 1 CARTON (62332-966-09) / 9 TABLET, COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 185MG BASE | ||||
| Approval Date: | Apr 24, 2024 | TE: | RLD: | Yes | |||||
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