Details for New Drug Application (NDA): 216150
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NDA 216150 describes ARIPIPRAZOLE, which is a drug marketed by Mylan, Amneal Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Lannett Co Inc, Rubicon, Vistapharm Llc, Alembic, Orbion Pharms, Sciegen Pharms Inc, Square Pharms, Accord Hlthcare, Aiping Pharm Inc, Ajanta Pharma Ltd, Alkem Labs Ltd, Aurobindo Pharma, Hetero Labs Ltd V, Lupin, Macleods Pharms Ltd, Norvium Bioscience, Prinston Inc, Sunshine, Teva Pharms Usa, Torrent, Unichem, and Zydus Pharms, and is included in thirty-five NDAs. It is available from forty-six suppliers. Additional details are available on the ARIPIPRAZOLE profile page.
The generic ingredient in ARIPIPRAZOLE is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
The generic ingredient in ARIPIPRAZOLE is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 216150
| Tradename: | ARIPIPRAZOLE |
| Applicant: | Hetero Labs Ltd Iii |
| Ingredient: | aripiprazole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216150
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARIPIPRAZOLE | aripiprazole | SOLUTION;ORAL | 216150 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0684 | 17856-0684-1 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0684-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0684-3) |
| ARIPIPRAZOLE | aripiprazole | SOLUTION;ORAL | 216150 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0684 | 17856-0684-2 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0684-2) / 10 mL in 1 CUP, UNIT-DOSE (17856-0684-4) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
| Approval Date: | Nov 1, 2023 | TE: | AA | RLD: | No | ||||
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