Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070589
Company: USL PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE;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
01/07/1987 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
01/11/2012 SUPPL-45 Labeling-Package Insert

Label is not available on this site.

07/28/2014 SUPPL-44 Labeling-Package Insert

Label is not available on this site.

06/05/2009 SUPPL-40 Labeling

Label is not available on this site.

02/09/2009 SUPPL-38 Labeling

Label is not available on this site.

11/19/2007 SUPPL-37 Labeling

Label is not available on this site.

11/17/2004 SUPPL-29 Labeling

Label is not available on this site.

10/31/2003 SUPPL-26 Labeling

Label is not available on this site.

03/26/2003 SUPPL-24 Labeling

Label is not available on this site.

12/16/1997 SUPPL-21 Labeling

Label is not available on this site.

10/18/1996 SUPPL-20 Labeling

Label is not available on this site.

10/18/1996 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/18/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/18/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/18/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/09/1995 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/09/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/24/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/24/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/24/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/24/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/24/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/16/1991 SUPPL-8 Labeling

Label is not available on this site.

02/26/1991 SUPPL-7 Labeling

Label is not available on this site.

02/26/1991 SUPPL-6 Labeling

Label is not available on this site.

03/27/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/26/1988 SUPPL-4 Labeling

Label is not available on this site.

05/05/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/07/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

AMANTADINE HYDROCHLORIDE

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 208966 ALEMBIC PHARMS LTD
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 078720 BIONPHARMA INC
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 209171 HERITAGE PHARMA
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 209221 LANNETT HOLDINGS INC
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 207570 NEWGEN PHARMS LLC
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 071293 SANDOZ
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 209047 STRIDES PHARMA
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 070589 USL PHARMA
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 208107 WATSON LABS INC
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 208278 ZYDUS PHARMS USA INC

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