Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212025
Company: SAGE CHEMS
Company: SAGE CHEMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
APOMORPHINE HYDROCHLORIDE | APOMORPHINE HYDROCHLORIDE | 30MG/3ML (10MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
02/23/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212025Orig1s000ltr.pdf |
APOMORPHINE HYDROCHLORIDE
INJECTABLE;SUBCUTANEOUS; 30MG/3ML (10MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
APOKYN | APOMORPHINE HYDROCHLORIDE | 30MG/3ML (10MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | Yes | AP | 021264 | MDD US |
APOMORPHINE HYDROCHLORIDE | APOMORPHINE HYDROCHLORIDE | 30MG/3ML (10MG/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 212025 | SAGE CHEMS |