Details for New Drug Application (NDA): 078702
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NDA 078702 describes CANDESARTAN CILEXETIL, which is a drug marketed by Alembic, Apotex, Macleods Pharms Ltd, Mylan, Prinston Inc, Zydus Lifesciences, Anda Repository, and Apotex Inc, and is included in thirteen NDAs. It is available from seven suppliers. Additional details are available on the CANDESARTAN CILEXETIL profile page.
The generic ingredient in CANDESARTAN CILEXETIL is candesartan cilexetil; hydrochlorothiazide. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.
The generic ingredient in CANDESARTAN CILEXETIL is candesartan cilexetil; hydrochlorothiazide. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.
Summary for 078702
| Tradename: | CANDESARTAN CILEXETIL |
| Applicant: | Mylan |
| Ingredient: | candesartan cilexetil |
| Patents: | 0 |
Pharmacology for NDA: 078702
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 078702
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CANDESARTAN CILEXETIL | candesartan cilexetil | TABLET;ORAL | 078702 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3224 | 0378-3224-77 | 90 TABLET in 1 BOTTLE, PLASTIC (0378-3224-77) |
| CANDESARTAN CILEXETIL | candesartan cilexetil | TABLET;ORAL | 078702 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3224 | 0378-3224-93 | 30 TABLET in 1 BOTTLE, PLASTIC (0378-3224-93) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | May 3, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 8MG | ||||
| Approval Date: | May 3, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 16MG | ||||
| Approval Date: | May 3, 2013 | TE: | AB | RLD: | No | ||||
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