اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ADAPALENE از شرکت GLENMARK GENERICS
Abbreviated New Drug Application (ANDA): 091314
Company: GLENMARK GENERICS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADAPALENE | ADAPALENE | 0.1% | GEL;TOPICAL | Over-the-counter |
None |
No | No |
| ADAPALENE | ADAPALENE | 0.1% | GEL;TOPICAL | Over-the-counter |
None |
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 |
|---|---|---|---|---|---|---|---|
| 07/01/2010 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/091314Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/09/2019 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
ADAPALENE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
GEL;TOPICAL; 0.1%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ADAPALENE | ADAPALENE | 0.1% | GEL;TOPICAL | Over-the-counter | No | 091314 | GLENMARK GENERICS |
| ADAPALENE | ADAPALENE | 0.1% | GEL;TOPICAL | Over-the-counter | No | 091314 | GLENMARK GENERICS |
| ADAPALENE | ADAPALENE | 0.1% | GEL;TOPICAL | Over-the-counter | No | 090962 | P AND L |
| DIFFERIN | ADAPALENE | 0.1% | GEL;TOPICAL | Over-the-counter | Yes | 020380 | GALDERMA LABS LP |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
GEL;TOPICAL; 0.1%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ADAPALENE | ADAPALENE | 0.1% | GEL;TOPICAL | Over-the-counter | No | 091314 | GLENMARK GENERICS |
| ADAPALENE | ADAPALENE | 0.1% | GEL;TOPICAL | Over-the-counter | No | 091314 | GLENMARK GENERICS |
| ADAPALENE | ADAPALENE | 0.1% | GEL;TOPICAL | Over-the-counter | No | 090962 | P AND L |
| DIFFERIN | ADAPALENE | 0.1% | GEL;TOPICAL | Over-the-counter | Yes | 020380 | GALDERMA LABS LP |
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