BIJUVA از شرکت THERAPEUTICSMD INC

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

New Drug Application (NDA): 210132

Company: THERAPEUTICSMD INC

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	None	Yes	Yes

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

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
06/22/2021	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (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 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

Action Date

Submission

Supplement Categories or Approval Type

Letters, Reviews, Labels, Patient Package Insert

Note

Url

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	Url
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

حتما بخوانید : BICNU از شرکت AVET LIFESCIENCES

منبع : www.accessdata.fda.gov

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BIJUVA از شرکت THERAPEUTICSMD INC