Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040220
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/29/1997 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
02/24/2014 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

02/24/2014 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

12/01/2009 SUPPL-19 Labeling

Label is not available on this site.

09/23/2008 SUPPL-16 Labeling

Label is not available on this site.

01/21/2003 SUPPL-10 Labeling

Label is not available on this site.

04/20/2001 SUPPL-8 Labeling

Label is not available on this site.

09/02/1999 SUPPL-7 Labeling

Label is not available on this site.

08/19/1998 SUPPL-5 Labeling

Label is not available on this site.

03/25/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/25/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/25/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

METHYLPHENIDATE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 206932 ABHAI INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 040220 ACTAVIS LABS FL INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 207416 ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 209753 BIONPHARMA INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 207587 BRECKENRIDGE PHARM
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 208737 CEDIPROF INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 206840 CNTY LINE PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091159 MOUNTAIN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 207884 NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202892 OXFORD PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 040300 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090710 SUN PHARM INDS INC
RITALIN METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 010187 NOVARTIS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 206932 ABHAI INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 040220 ACTAVIS LABS FL INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 207416 ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 209753 BIONPHARMA INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 207587 BRECKENRIDGE PHARM
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 208737 CEDIPROF INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 206840 CNTY LINE PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 091159 MOUNTAIN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 207884 NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 202892 OXFORD PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 040300 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090710 SUN PHARM INDS INC
RITALIN METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AB 010187 NOVARTIS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 206932 ABHAI INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 040220 ACTAVIS LABS FL INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 207416 ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 209753 BIONPHARMA INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 207587 BRECKENRIDGE PHARM
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 208737 CEDIPROF INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 206840 CNTY LINE PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 091159 MOUNTAIN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 207884 NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 202892 OXFORD PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 040300 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 090710 SUN PHARM INDS INC
RITALIN METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription Yes AB 010187 NOVARTIS

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