Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086996
Company: SANDOZ

Products on ANDA 086996

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 086996

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/28/1981	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-45	Labeling-Package Insert		Label is not available on this site.
10/09/2024	SUPPL-37	Labeling-Package Insert		Label is not available on this site.
08/29/2007	SUPPL-27	Labeling		Label is not available on this site.
03/01/2007	SUPPL-25	Labeling		Label is not available on this site.
12/09/2002	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
08/10/2000	SUPPL-18	Manufacturing (CMC)-Facility		Label is not available on this site.
01/12/2000	SUPPL-17	Labeling		Label is not available on this site.
11/13/1997	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
04/17/1996	SUPPL-15	Labeling		Label is not available on this site.
04/01/1996	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/01/1996	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
09/01/1993	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/06/1990	SUPPL-11	Labeling		Label is not available on this site.
09/04/1991	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
11/17/1988	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/17/1988	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/25/1987	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/10/1982	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/10/1982	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 086996

LANORINAL

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