Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 020580
Company: ORGANON USA INC
Company: ORGANON USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
COTAZYM | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 30,000USP UNITS;8,000USP UNITS;30,000USP UNITS | 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 |
---|---|---|---|---|---|---|---|
12/09/1996 | ORIG-1 | Approval | N/A |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/12/2000 | SUPPL-1 | Supplement |
Label is not available on this site. |