Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084092
Company: INVATECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG 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
03/19/1975 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
06/19/2007 SUPPL-106 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/2002 SUPPL-100 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/2002 SUPPL-99 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/2001 SUPPL-98 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

02/11/1999 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

02/11/1999 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

02/11/1999 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

02/11/1999 SUPPL-93 Labeling

Label is not available on this site.

11/07/1995 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

04/23/1996 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

05/22/1989 SUPPL-87 Labeling

Label is not available on this site.

04/24/1986 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

01/28/1987 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

03/01/1985 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

03/15/1984 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

03/15/1984 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

03/15/1984 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

03/15/1984 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

03/15/1984 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

01/25/1984 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

03/11/1982 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

03/11/1982 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

03/11/1982 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

03/11/1982 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

05/13/1982 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

05/13/1982 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

05/13/1982 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

MECLIZINE HYDROCHLORIDE

TABLET;ORAL; 25MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANTIVERT MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription Yes AA 010721 CASPER PHARMA LLC
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 201451 AMNEAL PHARMS
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 087128 ANNORA PHARMA
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 200294 EPIC PHARMA LLC
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 205136 INDICUS PHARMA
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 084092 INVATECH
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 040659 JUBILANT CADISTA
MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AA 213957 ZYDUS

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