Details for New Drug Application (NDA): 206367
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NDA 206367 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, Graviti Pharms, Hikma, Hikma Pharms, Invagen Pharms, Lupin, 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, Macleods Pharms Ltd, Novel Labs Inc, Teva Pharms Usa, Torrent, and Lupin Ltd, and is included in seventy-one NDAs. It is available from forty-one 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for 206367
| Tradename: | AMLODIPINE BESYLATE |
| Applicant: | Invagen Pharms |
| Ingredient: | amlodipine besylate |
| Patents: | 0 |
Pharmacology for NDA: 206367
| Mechanism of Action | Calcium Channel Antagonists |
Suppliers and Packaging for NDA: 206367
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 206367 | ANDA | Exelan Pharmaceuticals, Inc. | 76282-507 | 76282-507-05 | 500 TABLET in 1 BOTTLE (76282-507-05) |
| AMLODIPINE BESYLATE | amlodipine besylate | TABLET;ORAL | 206367 | ANDA | Exelan Pharmaceuticals, Inc. | 76282-507 | 76282-507-10 | 1000 TABLET in 1 BOTTLE (76282-507-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
| Approval Date: | Dec 10, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Dec 10, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Dec 10, 2015 | TE: | AB | RLD: | No | ||||
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