Details for New Drug Application (NDA): 202516
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NDA 202516 describes TELMISARTAN AND AMLODIPINE, which is a drug marketed by Alembic, Lupin Ltd, Mylan, and Torrent, and is included in four NDAs. It is available from two suppliers. Additional details are available on the TELMISARTAN AND AMLODIPINE profile page.
The generic ingredient in TELMISARTAN AND AMLODIPINE is amlodipine besylate; telmisartan. There are fifty drug master file entries for this compound. Two 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 are fifty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amlodipine besylate; telmisartan profile page.
Summary for 202516
| Tradename: | TELMISARTAN AND AMLODIPINE |
| Applicant: | Mylan |
| Ingredient: | amlodipine besylate; telmisartan |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202516
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TELMISARTAN AND AMLODIPINE | amlodipine besylate; telmisartan | TABLET;ORAL | 202516 | ANDA | Mylan Pharmaceuticals Inc. | 0378-1075 | 0378-1075-93 | 30 TABLET in 1 BOTTLE, PLASTIC (0378-1075-93) |
| TELMISARTAN AND AMLODIPINE | amlodipine besylate; telmisartan | TABLET;ORAL | 202516 | ANDA | Mylan Pharmaceuticals Inc. | 0378-1076 | 0378-1076-93 | 30 TABLET in 1 BOTTLE, PLASTIC (0378-1076-93) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;40MG | ||||
| Approval Date: | Aug 26, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE;40MG | ||||
| Approval Date: | Aug 26, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;80MG | ||||
| Approval Date: | Aug 26, 2014 | TE: | AB | RLD: | No | ||||
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