Details for New Drug Application (NDA): 216357
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NDA 216357 describes NICARDIPINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Norvium Bioscience, Senores Pharms, Skg Pharma, Am Regent, Chengdu Shuode, Eugia Pharma, Hikma Intl Pharms, Micro Labs, Navinta Llc, Rk Pharma, Sun Pharm, West-ward Pharms Int, Wockhardt, and Inforlife, and is included in twenty NDAs. It is available from twenty-one suppliers. Additional details are available on the NICARDIPINE HYDROCHLORIDE profile page.
The generic ingredient in NICARDIPINE HYDROCHLORIDE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
The generic ingredient in NICARDIPINE HYDROCHLORIDE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 216357
| Tradename: | NICARDIPINE HYDROCHLORIDE |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | nicardipine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216357
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | CAPSULE;ORAL | 216357 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-120 | 68462-120-05 | 500 CAPSULE in 1 BOTTLE (68462-120-05) |
| NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | CAPSULE;ORAL | 216357 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-120 | 68462-120-90 | 90 CAPSULE in 1 BOTTLE (68462-120-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| Approval Date: | Dec 16, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
| Approval Date: | Dec 16, 2022 | TE: | AB | RLD: | No | ||||
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