Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074940
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Discontinued | None | No | No |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 10/30/1997 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/074940.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/03/2015 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
||
| 10/15/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/26/2002 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 12/15/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 10/26/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |