Details for New Drug Application (NDA): 213911
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NDA 213911 describes DROXIDOPA, which is a drug marketed by 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, Yampa, 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 213911
| Tradename: | DROXIDOPA |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | droxidopa |
| Patents: | 0 |
Pharmacology for NDA: 213911
| Physiological Effect | Increased Blood Pressure |
Medical Subject Heading (MeSH) Categories for 213911
Suppliers and Packaging for NDA: 213911
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DROXIDOPA | droxidopa | CAPSULE;ORAL | 213911 | ANDA | Ascend Laboratories, LLC | 67877-704 | 67877-704-05 | 500 CAPSULE in 1 BOTTLE (67877-704-05) |
| DROXIDOPA | droxidopa | CAPSULE;ORAL | 213911 | ANDA | Ascend Laboratories, LLC | 67877-704 | 67877-704-90 | 90 CAPSULE in 1 BOTTLE (67877-704-90) |
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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