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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761118
Company: PFIZER INC

Medication Guide

Products on BLA 761118

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ABRILADA	ADALIMUMAB-AFZB	40MG/0.8ML	INJECTABLE;INJECTION	Prescription	None	No	No
ABRILADA	ADALIMUMAB-AFZB	20MG/0.4ML	INJECTABLE;INJECTION	Prescription	None	No	No
ABRILADA	ADALIMUMAB-AFZB	10MG/0.2ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761118

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/15/2019	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761118s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761118Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761118Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2024	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761118Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761118Orig1s012ltr.pdf
08/16/2023	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761118s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761118Orig1s011ltr.pdf
06/14/2023	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761118s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761118Orig1s009ltr.pdf
10/04/2023	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761118s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761118Orig1s007ltr.pdf
07/29/2022	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761118s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761118Orig1s006ltr.pdf

Labels for BLA 761118

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2024	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761118Orig1s012lbl.pdf
04/30/2024	SUPPL-12	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761118Orig1s012lbl.pdf
10/04/2023	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761118s007lbl.pdf
08/16/2023	SUPPL-11	Bioequivalence	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761118s011lbl.pdf
06/14/2023	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761118s009lbl.pdf
07/29/2022	SUPPL-6	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761118s006lbl.pdf
07/29/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761118s006lbl.pdf
11/15/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761118s000lbl.pdf

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