Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091033
Company: HIKMA FARMACEUTICA
Company: HIKMA FARMACEUTICA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROGESTERONE | PROGESTERONE | 50MG/ML | INJECTABLE;INJECTION | Prescription | AO | 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 |
---|---|---|---|---|---|---|---|
10/28/2010 | 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 |
---|---|---|---|---|---|
05/08/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
PROGESTERONE
INJECTABLE;INJECTION; 50MG/ML
TE Code = AO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROGESTERONE | PROGESTERONE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 210965 | EUGIA PHARMA |
PROGESTERONE | PROGESTERONE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 075906 | FRESENIUS KABI USA |
PROGESTERONE | PROGESTERONE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 091033 | HIKMA FARMACEUTICA |
PROGESTERONE | PROGESTERONE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 215634 | XIROMED |