Details for New Drug Application (NDA): 091154
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NDA 091154 describes AMLODIPINE AND OLMESARTAN MEDOXOMIL, which is a drug marketed by Accord Hlthcare Inc, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Micro Labs, Sciegen Pharms Inc, Teva Pharms Usa, Torrent, and Zydus Pharms, and is included in thirteen NDAs. It is available from fifteen suppliers. Additional details are available on the AMLODIPINE AND OLMESARTAN MEDOXOMIL profile page.
The generic ingredient in AMLODIPINE AND OLMESARTAN MEDOXOMIL is amlodipine besylate; olmesartan medoxomil. There are fifty drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; olmesartan medoxomil profile page.
The generic ingredient in AMLODIPINE AND OLMESARTAN MEDOXOMIL is amlodipine besylate; olmesartan medoxomil. There are fifty drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; olmesartan medoxomil profile page.
Summary for 091154
| Tradename: | AMLODIPINE AND OLMESARTAN MEDOXOMIL |
| Applicant: | Teva Pharms Usa |
| Ingredient: | amlodipine besylate; olmesartan medoxomil |
| Patents: | 0 |
Pharmacology for NDA: 091154
| Mechanism of Action | Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists |
Suppliers and Packaging for NDA: 091154
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | amlodipine besylate; olmesartan medoxomil | TABLET;ORAL | 091154 | ANDA | medsource pharmaceuticals | 45865-901 | 45865-901-30 | 30 TABLET, FILM COATED in 1 BOTTLE (45865-901-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;20MG | ||||
| Approval Date: | Oct 26, 2016 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;40MG | ||||
| Approval Date: | Oct 26, 2016 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE;20MG | ||||
| Approval Date: | Oct 26, 2016 | TE: | RLD: | No | |||||
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