Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212357
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | 5% | 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 |
---|---|---|---|---|---|---|---|
08/16/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212357Orig1s000TA_ltr.pdf |
DOXEPIN HYDROCHLORIDE
CREAM;TOPICAL; 5%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | 5% | CREAM;TOPICAL | Prescription | No | AB | 212357 | AMNEAL |
DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | 5% | CREAM;TOPICAL | Prescription | No | AB | 215408 | TEVA PHARMS |
ZONALON | DOXEPIN HYDROCHLORIDE | 5% | CREAM;TOPICAL | Prescription | Yes | AB | 020126 | MYLAN |