Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021674
Company: BAYER HLTHCARE
Company: BAYER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MENOSTAR | ESTRADIOL | 0.014MG/24HR | SYSTEM;TRANSDERMAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/08/2004 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21674_menostar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21674ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021674_s000_MenostarTOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/08/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21674_menostar_lbl.pdf |
MENOSTAR
SYSTEM;TRANSDERMAL; 0.014MG/24HR
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | ESTRADIOL | 0.014MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB | 204379 | ZYDUS PHARMS |
MENOSTAR | ESTRADIOL | 0.014MG/24HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB | 021674 | BAYER HLTHCARE |