Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075100
Company: LEK PHARM
Company: LEK PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BROMOCRIPTINE MESYLATE | BROMOCRIPTINE MESYLATE | EQ 5MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/10/1998 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75100ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75100_Bromocriptine.cfm |