Details for New Drug Application (NDA): 218618
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NDA 218618 describes CABERGOLINE, which is a drug marketed by Actavis Labs Fl Inc, Apotex Corp, Impax Labs Inc, Ingenus Pharms Llc, Ivax Sub Teva Pharms, Norvium Bioscience, Skg Pharma, Somerset Theraps Llc, and Strides Pharma, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the CABERGOLINE profile page.
The generic ingredient in CABERGOLINE is cabergoline. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the cabergoline profile page.
The generic ingredient in CABERGOLINE is cabergoline. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the cabergoline profile page.
Summary for 218618
| Tradename: | CABERGOLINE |
| Applicant: | Skg Pharma |
| Ingredient: | cabergoline |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218618
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CABERGOLINE | cabergoline | TABLET;ORAL | 218618 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2693 | 69238-2693-1 | 8 TABLET in 1 BOTTLE (69238-2693-1) |
| CABERGOLINE | cabergoline | TABLET;ORAL | 218618 | ANDA | SKG Pharma Inc. | 83085-003 | 83085-003-08 | 8 TABLET in 1 BOTTLE (83085-003-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Jun 26, 2024 | TE: | AB | RLD: | No | ||||
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