Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020404
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AVITA | TRETINOIN | 0.025% | CREAM;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 |
---|---|---|---|---|---|---|---|
01/14/1997 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/22/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/30/2001 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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03/31/2000 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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12/15/1999 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
AVITA
CREAM;TOPICAL; 0.025%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AVITA | TRETINOIN | 0.025% | CREAM;TOPICAL | Prescription | No | AB | 020404 | MYLAN PHARMS INC |
RETIN-A | TRETINOIN | 0.025% | CREAM;TOPICAL | Prescription | Yes | AB | 019049 | BAUSCH |
TRETINOIN | TRETINOIN | 0.025% | CREAM;TOPICAL | Prescription | No | AB | 075264 | PADAGIS US |
TRETINOIN | TRETINOIN | 0.025% | CREAM;TOPICAL | Prescription | No | AB | 215713 | TARO |