Details for New Drug Application (NDA): 216521
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NDA 216521 describes DILTIAZEM HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Actavis Labs Fl Inc, Apotex, Biovail, Dr Reddys Labs Sa, Endo Operations, Glenmark Pharms Ltd, Mylan, Nesher Pharms, Norvium Bioscience, Novast Labs, Sandoz, Sun Pharm, Teva, Twi Pharms, Utopic Pharms, Valeant Pharms North, Zydus Pharms, Dr Reddys, Eugia Pharma, Hikma, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Rising, Sagent, Amta, Sciegen Pharms Inc, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, Teva Pharms, and Exela Pharma, and is included in fifty NDAs. It is available from forty-six suppliers. Additional details are available on the DILTIAZEM HYDROCHLORIDE profile page.
The generic ingredient in DILTIAZEM HYDROCHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
The generic ingredient in DILTIAZEM HYDROCHLORIDE is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 216521
| Tradename: | DILTIAZEM HYDROCHLORIDE |
| Applicant: | Sciegen Pharms Inc |
| Ingredient: | diltiazem hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216521
| Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors |
Suppliers and Packaging for NDA: 216521
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | TABLET;ORAL | 216521 | ANDA | A-S Medication Solutions | 50090-7401 | 50090-7401-2 | 30 TABLET in 1 BOTTLE (50090-7401-2) |
| DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | TABLET;ORAL | 216521 | ANDA | A-S Medication Solutions | 50090-7401 | 50090-7401-3 | 90 TABLET in 1 BOTTLE (50090-7401-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Sep 23, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Sep 23, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
| Approval Date: | Sep 23, 2022 | TE: | AB | RLD: | No | ||||
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