FDA Approval for MEDROXYPROGESTERONE ACETATE issued to AMPHASTAR PHARMS INC
$AMPH
Biotechnology: Pharmaceutical Preparations
Health Care
Abbreviated New Drug Application (ANDA): 077334
Company: AMPHASTAR PHARMS INC
Company: AMPHASTAR PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 11/28/2017 | 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 |
|---|---|---|---|---|---|
| 01/25/2024 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
MEDROXYPROGESTERONE ACETATE
INJECTABLE;INJECTION; 150MG/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AB | 020246 | PFIZER |
| MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 215397 | AMNEAL |
| MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 077235 | AMPHASTAR PHARMS INC |
| MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 077334 | AMPHASTAR PHARMS INC |
| MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 212824 | EUGIA PHARMA |
| MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 212844 | EUGIA PHARMA |
| MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 076553 | MEITHEAL |
| MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 210227 | MYLAN LABS LTD |