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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078149
Company: MPP PHARMA

Products on ANDA 078149

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUTALBITAL, ASPIRIN AND CAFFEINE	ASPIRIN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	CAPSULE;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078149

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/2007	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
03/20/2008	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
03/20/2008	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 078149

BUTALBITAL, ASPIRIN AND CAFFEINE

CAPSULE;ORAL; 325MG;50MG;40MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUTALBITAL, ASPIRIN AND CAFFEINE	ASPIRIN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	078149	MPP PHARMA
LANORINAL	ASPIRIN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG	CAPSULE;ORAL	Prescription	No	AA	086996	SANDOZ

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