Details for New Drug Application (NDA): 203508
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NDA 203508 describes LISINOPRIL, which is a drug marketed by Accord Hlthcare, Ascent Pharms Inc, Aurobindo, Chartwell Rx, Corepharma, Heritage Pharma, Hikma Intl Pharms, Invagen Pharms, Lupin, Prinston Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Teva, Watson Labs, Wockhardt Bio Ag, Epic Pharma Llc, Norvium Bioscience, and Sandoz, and is included in thirty-two NDAs. It is available from forty-two suppliers. Additional details are available on the LISINOPRIL profile page.
The generic ingredient in LISINOPRIL is hydrochlorothiazide; lisinopril. There are thirty-two drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.
The generic ingredient in LISINOPRIL is hydrochlorothiazide; lisinopril. There are thirty-two drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.
Summary for 203508
| Tradename: | LISINOPRIL |
| Applicant: | Invagen Pharms |
| Ingredient: | lisinopril |
| Patents: | 0 |
Pharmacology for NDA: 203508
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Medical Subject Heading (MeSH) Categories for 203508
Suppliers and Packaging for NDA: 203508
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LISINOPRIL | lisinopril | TABLET;ORAL | 203508 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-009 | 43353-009-30 | 30 TABLET in 1 BOTTLE (43353-009-30) |
| LISINOPRIL | lisinopril | TABLET;ORAL | 203508 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-009 | 43353-009-45 | 45 TABLET in 1 BOTTLE (43353-009-45) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Oct 29, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Oct 29, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 29, 2013 | TE: | AB | RLD: | No | ||||
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