Details for New Drug Application (NDA): 019777
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NDA 019777 describes ZESTRIL, which is a drug marketed by Twi Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the ZESTRIL profile page.
The generic ingredient in ZESTRIL is lisinopril. There are twenty-one drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the lisinopril profile page.
The generic ingredient in ZESTRIL is lisinopril. There are twenty-one drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the lisinopril profile page.
Summary for 019777
| Tradename: | ZESTRIL |
| Applicant: | Twi Pharms |
| Ingredient: | lisinopril |
| Patents: | 0 |
Pharmacology for NDA: 019777
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Medical Subject Heading (MeSH) Categories for 019777
Suppliers and Packaging for NDA: 019777
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZESTRIL | lisinopril | TABLET;ORAL | 019777 | NDA | Upsher-Smith Laboratories, LLC | 24979-238 | 24979-238-07 | 90 TABLET in 1 BOTTLE (24979-238-07) |
| ZESTRIL | lisinopril | TABLET;ORAL | 019777 | NDA | Upsher-Smith Laboratories, LLC | 24979-239 | 24979-239-07 | 90 TABLET in 1 BOTTLE (24979-239-07) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | May 19, 1988 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 19, 1988 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | May 19, 1988 | TE: | AB | RLD: | Yes | ||||
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