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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090999
Company: SANDOZ

Products on ANDA 090999

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
APREPITANT	APREPITANT	40MG	CAPSULE;ORAL	Prescription	AB	No	No
APREPITANT	APREPITANT	80MG	CAPSULE;ORAL	Prescription	AB	No	No
APREPITANT	APREPITANT	125MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090999

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/24/2012	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/090999Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
12/23/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
09/28/2016	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/28/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
07/20/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/20/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090999

APREPITANT

CAPSULE;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APREPITANT	APREPITANT	40MG	CAPSULE;ORAL	Prescription	No	AB	207777	GLENMARK PHARMS SA
APREPITANT	APREPITANT	40MG	CAPSULE;ORAL	Prescription	No	AB	090999	SANDOZ
APREPITANT	APREPITANT	40MG	CAPSULE;ORAL	Prescription	No	AB	211835	TORRENT

CAPSULE;ORAL; 80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APREPITANT	APREPITANT	80MG	CAPSULE;ORAL	Prescription	No	AB	207777	GLENMARK PHARMS SA
APREPITANT	APREPITANT	80MG	CAPSULE;ORAL	Prescription	No	AB	090999	SANDOZ
APREPITANT	APREPITANT	80MG	CAPSULE;ORAL	Prescription	No	AB	211835	TORRENT
EMEND	APREPITANT	80MG	CAPSULE;ORAL	Prescription	Yes	AB	021549	MERCK

CAPSULE;ORAL; 125MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APREPITANT	APREPITANT	125MG	CAPSULE;ORAL	Prescription	No	AB	207777	GLENMARK PHARMS SA
APREPITANT	APREPITANT	125MG	CAPSULE;ORAL	Prescription	No	AB	090999	SANDOZ
APREPITANT	APREPITANT	125MG	CAPSULE;ORAL	Prescription	No	AB	211835	TORRENT
EMEND	APREPITANT	125MG	CAPSULE;ORAL	Prescription	Yes	AB	021549	MERCK

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