Details for New Drug Application (NDA): 218618
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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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