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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210132
Company: MAYNE PHARMA

Products on NDA 210132

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BIJUVA	ESTRADIOL; PROGESTERONE	1MG;100MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes
BIJUVA	ESTRADIOL; PROGESTERONE	0.5MG;100MG	CAPSULE;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210132

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2018	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210132s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210132Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210132Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210132s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210132Orig1s011ltr.pdf
12/28/2021	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210132Orig1s006ltr.pdf
06/22/2021	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210132Orig1s001, s003ltr.pdf
06/22/2021	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210132Orig1s001, s003ltr.pdf

Labels for NDA 210132

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210132s011lbl.pdf
12/28/2021	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s006lbl.pdf
06/22/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s001s003lbl.pdf
06/22/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210132s001s003lbl.pdf
10/28/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210132s000lbl.pdf

Therapeutic Equivalents for NDA 210132

BIJUVA

CAPSULE;ORAL; 1MG;100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BIJUVA	ESTRADIOL; PROGESTERONE	1MG;100MG	CAPSULE;ORAL	Prescription	Yes	AB	210132	MAYNE PHARMA

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