Details for New Drug Application (NDA): 040903
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NDA 040903 describes IMIPRAMINE HYDROCHLORIDE, which is a drug marketed by Novartis, Chartwell, Leading, Lederle, Oxford Pharms, Par Pharm, Roxane, Sandoz, Specgx Llc, Strides Pharma Intl, Sun Pharm Industries, Teva, Usl Pharma, Vangard, Watson Labs, and West Ward, and is included in thirty-six NDAs. It is available from twelve suppliers. Additional details are available on the IMIPRAMINE HYDROCHLORIDE profile page.
The generic ingredient in IMIPRAMINE HYDROCHLORIDE is imipramine hydrochloride. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the imipramine hydrochloride profile page.
The generic ingredient in IMIPRAMINE HYDROCHLORIDE is imipramine hydrochloride. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the imipramine hydrochloride profile page.
Summary for 040903
| Tradename: | IMIPRAMINE HYDROCHLORIDE |
| Applicant: | Leading |
| Ingredient: | imipramine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 040903
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IMIPRAMINE HYDROCHLORIDE | imipramine hydrochloride | TABLET;ORAL | 040903 | ANDA | A-S Medication Solutions | 50090-3148 | 50090-3148-0 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-3148-0) |
| IMIPRAMINE HYDROCHLORIDE | imipramine hydrochloride | TABLET;ORAL | 040903 | ANDA | Coupler LLC | 67046-1564 | 67046-1564-3 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1564-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 24, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Oct 24, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Oct 24, 2012 | TE: | AB | RLD: | No | ||||
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