Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208381
Company: SUN PHARM
Company: SUN PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROXYPROGESTERONE CAPROATE | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | AP1 | 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 |
---|---|---|---|---|---|---|---|
04/09/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
HYDROXYPROGESTERONE CAPROATE
SOLUTION;INTRAMUSCULAR; 1250MG/5ML (250MG/ML)
TE Code = AP1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROXYPROGESTERON CAPROATE | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AP1 | 210724 | AM REGENT |
HYDROXYPROGESTERONE CAPROATE | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AP1 | 211070 | EUGIA PHARMA |
HYDROXYPROGESTERONE CAPROATE | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AP1 | 210618 | SLAYBACK PHARMA LLC |
HYDROXYPROGESTERONE CAPROATE | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | No | AP1 | 208381 | SUN PHARM |
MAKENA | HYDROXYPROGESTERONE CAPROATE | 1250MG/5ML (250MG/ML) | SOLUTION;INTRAMUSCULAR | Prescription | Yes | AP1 | 021945 | AMAG PHARMA USA |
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