Details for New Drug Application (NDA): 211596
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NDA 211596 describes DILTIAZEM HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Actavis Labs Fl Inc, Amta, Apotex, Biovail, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Mylan, Nesher Pharms, Novast Labs, Par Pharm, Sandoz, Sun Pharm, Teva, Twi Pharms, Valeant Pharms North, Zydus Pharms, Dr Reddys, Eugia Pharma, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, Rising, Sagent, West-ward Pharms Int, 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-three 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. Forty-nine 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. Forty-nine suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 211596
| Tradename: | DILTIAZEM HYDROCHLORIDE |
| Applicant: | Edenbridge Pharms |
| Ingredient: | diltiazem hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211596
| Mechanism of Action | Calcium Channel Antagonists |
Suppliers and Packaging for NDA: 211596
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | TABLET;ORAL | 211596 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-129 | 42799-129-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42799-129-01) |
| DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | TABLET;ORAL | 211596 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-129 | 42799-129-02 | 500 TABLET, FILM COATED in 1 BOTTLE (42799-129-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Nov 18, 2019 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Nov 18, 2019 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
| Approval Date: | Nov 18, 2019 | TE: | RLD: | No | |||||
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