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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213115
Company: GRANULES

Products on ANDA 213115

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	300MG;50MG	CAPSULE;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213115

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/22/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/213115Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 213115

BUTALBITAL AND ACETAMINOPHEN

CAPSULE;ORAL; 300MG;50MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	300MG;50MG	CAPSULE;ORAL	Prescription	No	AA	207313	DR REDDYS LABS SA
BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL	300MG;50MG	CAPSULE;ORAL	Prescription	No	AA	213115	GRANULES

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