Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 075589
Company: PERRIGO PHARMA INTL
Company: PERRIGO PHARMA INTL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRETINOIN | TRETINOIN | 0.01% | 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 |
|---|---|---|---|---|---|---|---|
| 06/11/2002 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/25/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/21/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
TRETINOIN
GEL;TOPICAL; 0.01%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RETIN-A | TRETINOIN | 0.01% | GEL;TOPICAL | Prescription | Yes | AB | 017955 | VALEANT INTL |
| TRETINOIN | TRETINOIN | 0.01% | GEL;TOPICAL | Prescription | No | AB | 075589 | PERRIGO PHARMA INTL |
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