Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076553
Company: HONG KONG
Company: HONG KONG
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 |
---|---|---|---|---|---|---|---|
07/28/2004 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76553ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076553_S000_MedroxyprogesteroneTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/08/2021 | SUPPL-31 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
12/08/2021 | SUPPL-30 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
12/08/2021 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
12/08/2021 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
11/30/2011 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
03/04/2005 | SUPPL-2 | Labeling |
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 | HONG KONG |
MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 210227 | XIROMED |