Details for New Drug Application (NDA): 017962
✉ Email this page to a colleague
The generic ingredient in PARLODEL is bromocriptine mesylate. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.
Summary for 017962
Tradename: | PARLODEL |
Applicant: | Ss Pharma |
Ingredient: | bromocriptine mesylate |
Patents: | 0 |
Suppliers and Packaging for NDA: 017962
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PARLODEL | bromocriptine mesylate | CAPSULE;ORAL | 017962 | NDA | Validus Pharmaceuticals LLC | 30698-201 | 30698-201-01 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-201-01) |
PARLODEL | bromocriptine mesylate | CAPSULE;ORAL | 017962 | NDA | Validus Pharmaceuticals LLC | 30698-201 | 30698-201-30 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-201-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Mar 1, 1982 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 017962
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ss Pharma | PARLODEL | bromocriptine mesylate | CAPSULE;ORAL | 017962-002 | Mar 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Ss Pharma | PARLODEL | bromocriptine mesylate | TABLET;ORAL | 017962-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Ss Pharma | PARLODEL | bromocriptine mesylate | TABLET;ORAL | 017962-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription