Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071293
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/18/1987 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
03/25/2009 SUPPL-31 Labeling

Label is not available on this site.

11/20/2008 SUPPL-29 Labeling

Label is not available on this site.

04/01/2008 SUPPL-28 Labeling

Label is not available on this site.

05/11/2004 SUPPL-21 Labeling

Label is not available on this site.

11/08/2002 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/08/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/2002 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

02/07/2002 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/07/2002 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

10/17/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/07/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-7 Labeling

Label is not available on this site.

01/25/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/28/1994 SUPPL-5 Labeling

Label is not available on this site.

09/11/1991 SUPPL-4 Labeling

Label is not available on this site.

06/27/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/14/1989 SUPPL-2 Labeling

Label is not available on this site.

03/30/1988 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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