Details for New Drug Application (NDA): 201586
NDA 201586 describes TELMISARTAN AND AMLODIPINE, which is a drug marketed by Alembic, Lupin, Mylan, and Torrent, and is included in four NDAs. It is available from three suppliers. Additional details are available on the TELMISARTAN AND AMLODIPINE profile page.
The generic ingredient in TELMISARTAN AND AMLODIPINE is amlodipine besylate; telmisartan. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the amlodipine besylate; telmisartan profile page.
The generic ingredient in TELMISARTAN AND AMLODIPINE is amlodipine besylate; telmisartan. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the amlodipine besylate; telmisartan profile page.
Summary for 201586
| Tradename: | TELMISARTAN AND AMLODIPINE |
| Applicant: | Lupin |
| Ingredient: | amlodipine besylate; telmisartan |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;40MG | ||||
| Approval Date: | Jan 8, 2014 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE;40MG | ||||
| Approval Date: | Jan 8, 2014 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;80MG | ||||
| Approval Date: | Jan 8, 2014 | TE: | RLD: | No | |||||
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