Drugs@FDA: FDA-Approved Drugs
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRETINOIN | TRETINOIN | 0.05% | CREAM;TOPICAL | Prescription | AB1 | 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 |
---|---|---|---|---|---|---|---|
12/24/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75265_Tretinoin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75213ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75265_Tretinoin.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/20/2007 | SUPPL-26 | Labeling |
Label is not available on this site. |
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02/21/2007 | SUPPL-24 | Labeling |
Label is not available on this site. |
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10/24/2001 | SUPPL-15 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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10/24/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/24/2001 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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01/23/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/01/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/01/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/23/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/23/2001 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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02/29/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/23/1999 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/24/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75265_Tretinoin_prntlbl.pdf |
TRETINOIN
CREAM;TOPICAL; 0.05%
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RETIN-A | TRETINOIN | 0.05% | CREAM;TOPICAL | Prescription | Yes | AB1 | 017522 | VALEANT BERMUDA |
TRETINOIN | TRETINOIN | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 075265 | PADAGIS US |
TRETINOIN | TRETINOIN | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211644 | TARO |