Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088235
Company: CMP PHARMA INC
Company: CMP PHARMA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISONIAZID | ISONIAZID | 50MG/5ML | SYRUP;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/10/1983 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/09/2000 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/14/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/14/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |