Details for New Drug Application (NDA): 017962
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NDA 017962 describes PARLODEL, which is a drug marketed by Esjay Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the PARLODEL profile page.
The generic ingredient in PARLODEL is bromocriptine mesylate. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.
The generic ingredient in PARLODEL is bromocriptine mesylate. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.
Summary for 017962
| Tradename: | PARLODEL |
| Applicant: | Esjay 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 | ANI Pharmaceuticals, Inc. | 70954-978 | 70954-978-10 | 30 TABLET in 1 BOTTLE (70954-978-10) |
| PARLODEL | bromocriptine mesylate | CAPSULE;ORAL | 017962 | NDA | ANI Pharmaceuticals, Inc. | 70954-978 | 70954-978-20 | 100 TABLET in 1 BOTTLE (70954-978-20) |
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| Dosage: | CAPSULE;ORAL | Strength | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 |
|---|---|---|---|---|---|---|---|
| Esjay Pharma | PARLODEL | bromocriptine mesylate | CAPSULE;ORAL | 017962-002 | Mar 1, 1982 | 3,752,814 | ⤷ Get Started Free |
| Esjay Pharma | PARLODEL | bromocriptine mesylate | TABLET;ORAL | 017962-001 | Approved Prior to Jan 1, 1982 | 3,752,888 | ⤷ Get Started Free |
| Esjay Pharma | PARLODEL | bromocriptine mesylate | TABLET;ORAL | 017962-001 | Approved Prior to Jan 1, 1982 | 3,752,814 | ⤷ Get Started Free |
| Esjay Pharma | PARLODEL | bromocriptine mesylate | CAPSULE;ORAL | 017962-002 | Mar 1, 1982 | 3,752,888 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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