Details for New Drug Application (NDA): 206134
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NDA 206134 describes BUDESONIDE, which is a drug marketed by Padagis Israel, Amneal Pharms, Aurobindo Pharma Usa, Barr Labs Div Teva, Dr Reddys Labs Sa, Natco, Rising, Sciecure Pharma Inc, Zydus Pharms, Apotex, Cipla, Eugia Pharma, Impax Labs Inc, Lupin, Nephron, Sandoz, Sun Pharm, Teva Pharms, Teva Pharms Usa, Actavis Labs Fl Inc, Mylan, and Teva Pharms Usa Inc, and is included in twenty-two NDAs. It is available from thirty-one suppliers. Additional details are available on the BUDESONIDE profile page.
The generic ingredient in BUDESONIDE is budesonide; formoterol fumarate dihydrate. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the budesonide; formoterol fumarate dihydrate profile page.
The generic ingredient in BUDESONIDE is budesonide; formoterol fumarate dihydrate. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the budesonide; formoterol fumarate dihydrate profile page.
Summary for 206134
| Tradename: | BUDESONIDE |
| Applicant: | Zydus Pharms |
| Ingredient: | budesonide |
| Patents: | 0 |
Pharmacology for NDA: 206134
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 206134
Suppliers and Packaging for NDA: 206134
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUDESONIDE | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 206134 | ANDA | Major Pharmaceuticals | 0904-7313 | 0904-7313-10 | 20 BLISTER PACK in 1 CARTON (0904-7313-10) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK |
| BUDESONIDE | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 206134 | ANDA | Northstar Rx LLC. | 16714-829 | 16714-829-01 | 100 CAPSULE, COATED PELLETS in 1 BOTTLE (16714-829-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 3MG | ||||
| Approval Date: | May 4, 2017 | TE: | AB | RLD: | No | ||||
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