Details for New Drug Application (NDA): 214391
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NDA 214391 describes DROXIDOPA, which is a drug marketed by Adaptis, Ajanta Pharma Ltd, Alkem Labs Ltd, Annora, Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Hikma, Lupin Pharms, Msn Pharms Inc, Sciegen Pharms Inc, Somerset Theraps Llc, Sun Pharm, Teva Pharms Usa Inc, Upsher Smith Labs, and Zydus Pharms, and is included in sixteen NDAs. It is available from fifteen suppliers. Additional details are available on the DROXIDOPA profile page.
The generic ingredient in DROXIDOPA is droxidopa. There are six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the droxidopa profile page.
The generic ingredient in DROXIDOPA is droxidopa. There are six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the droxidopa profile page.
Summary for 214391
| Tradename: | DROXIDOPA |
| Applicant: | Ajanta Pharma Ltd |
| Ingredient: | droxidopa |
| Patents: | 0 |
Pharmacology for NDA: 214391
| Physiological Effect | Increased Blood Pressure |
Medical Subject Heading (MeSH) Categories for 214391
Suppliers and Packaging for NDA: 214391
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DROXIDOPA | droxidopa | CAPSULE;ORAL | 214391 | ANDA | Ajanta Pharma USA Inc. | 27241-199 | 27241-199-90 | 90 CAPSULE in 1 BOTTLE (27241-199-90) |
| DROXIDOPA | droxidopa | CAPSULE;ORAL | 214391 | ANDA | Ajanta Pharma USA Inc. | 27241-200 | 27241-200-90 | 90 CAPSULE in 1 BOTTLE (27241-200-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Feb 18, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
| Approval Date: | Feb 18, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Feb 18, 2021 | TE: | AB | RLD: | No | ||||
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