Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075529
Company: PADAGIS US
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRETINOIN | TRETINOIN | 0.025% | GEL;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
02/22/2000 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75529ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75529_Tretinoin.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/20/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
02/21/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
07/11/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/13/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/26/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
TRETINOIN
GEL;TOPICAL; 0.025%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RETIN-A | TRETINOIN | 0.025% | GEL;TOPICAL | Prescription | Yes | AB | 017579 | VALEANT INTL |
TRETINOIN | TRETINOIN | 0.025% | GEL;TOPICAL | Prescription | No | AB | 075529 | PADAGIS US |