Details for New Drug Application (NDA): 078925
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NDA 078925 describes AMLODIPINE BESYLATE, which is a drug marketed by Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Aurobindo Pharma, Chartwell Rx, China Resources, Cipla, Corepharma, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mylan, Norvium Bioscience, Orbion Pharms, Oxford Pharms, Polygen Pharms, Puracap Pharm, Sciegen Pharms Inc, Sovereign Pharms, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine, Teva, Torrent Pharms, Unichem, Watson Labs, Wockhardt, Zydus Pharms Usa, Apotex, Dr Reddys, Zydus Pharms, Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Teva Pharms, Watson Labs Inc, Alembic, Hetero Labs, Novel Labs Inc, Teva Pharms Usa, Torrent, and Lupin Ltd, and is included in sixty-nine NDAs. It is available from forty-three suppliers. Additional details are available on the AMLODIPINE BESYLATE profile page.
The generic ingredient in AMLODIPINE BESYLATE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
The generic ingredient in AMLODIPINE BESYLATE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for 078925
| Tradename: | AMLODIPINE BESYLATE |
| Applicant: | Alkem |
| Ingredient: | amlodipine besylate |
| Patents: | 0 |
Pharmacology for NDA: 078925
| Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Suppliers and Packaging for NDA: 078925
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 078925 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8429 | 0615-8429-05 | 15 TABLET in 1 BLISTER PACK (0615-8429-05) |
| AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 078925 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8429 | 0615-8429-39 | 30 TABLET in 1 BLISTER PACK (0615-8429-39) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
| Approval Date: | May 4, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | May 4, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | May 4, 2009 | TE: | AB | RLD: | No | ||||
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