Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077684
Company: BARR LABS INC
Company: BARR LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRETINOIN | TRETINOIN | 10MG | CAPSULE;ORAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
06/21/2007 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077684s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/24/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
TRETINOIN
CAPSULE;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TRETINOIN | TRETINOIN | 10MG | CAPSULE;ORAL | Prescription | No | AB | 201687 | ANCHEN PHARMS |
TRETINOIN | TRETINOIN | 10MG | CAPSULE;ORAL | Prescription | No | AB | 077684 | BARR LABS INC |
TRETINOIN | TRETINOIN | 10MG | CAPSULE;ORAL | Prescription | No | AB | 208279 | GLENMARK PHARMS LTD |