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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081265
Company: CHARTWELL RX

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 2MG TABLET;ORAL Prescription AA No No
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG TABLET;ORAL Prescription AA No No
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 0.5MG TABLET;ORAL Prescription AA 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
01/23/1992 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
05/15/2002 SUPPL-10 Labeling

Label is not available on this site.
05/16/2000 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.
05/16/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.
03/25/1998 SUPPL-7 Labeling

Label is not available on this site.
12/05/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
02/24/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
10/31/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
06/22/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
01/12/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
07/06/1993 SUPPL-1 Labeling

Label is not available on this site.

BENZTROPINE MESYLATE

TABLET;ORAL; 2MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 2MG TABLET;ORAL Prescription No AA 204713 ASPEN GLOBAL INC
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 2MG TABLET;ORAL Prescription No AA 081265 CHARTWELL RX
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 2MG TABLET;ORAL Prescription No AA 040715 ENDO OPERATIONS
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 2MG TABLET;ORAL Prescription No AA 072266 EPIC PHARMA LLC
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 2MG TABLET;ORAL Prescription No AA 090168 LEADING
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 2MG TABLET;ORAL Prescription No AA 089060 PLIVA

TABLET;ORAL; 1MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG TABLET;ORAL Prescription No AA 204713 ASPEN GLOBAL INC
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG TABLET;ORAL Prescription No AA 081265 CHARTWELL RX
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG TABLET;ORAL Prescription No AA 040715 ENDO OPERATIONS
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG TABLET;ORAL Prescription No AA 072265 EPIC PHARMA LLC
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG TABLET;ORAL Prescription No AA 090168 LEADING
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG TABLET;ORAL Prescription No AA 089059 PLIVA

TABLET;ORAL; 0.5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 0.5MG TABLET;ORAL Prescription No AA 204713 ASPEN GLOBAL INC
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 0.5MG TABLET;ORAL Prescription No AA 081265 CHARTWELL RX
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 0.5MG TABLET;ORAL Prescription No AA 040715 ENDO OPERATIONS
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 0.5MG TABLET;ORAL Prescription No AA 072264 EPIC PHARMA LLC
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 0.5MG TABLET;ORAL Prescription No AA 090168 LEADING
BENZTROPINE MESYLATE BENZTROPINE MESYLATE 0.5MG TABLET;ORAL Prescription No AA 089058 PLIVA
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