Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075906
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| 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 |
|---|---|---|---|---|---|---|---|
| 04/25/2001 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-906_Progesterone_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75906ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-906_Progesterone.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/27/2011 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/05/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/24/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/25/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-906_Progesterone_prntlbl.pdf |
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 | 217707 | ACCORD HLTHCARE |
| 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 |