Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074603
Company: WOCKHARDT BIO AG

Products on ANDA 074603

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GENERLAC	LACTULOSE	10GM/15ML	SOLUTION;ORAL, RECTAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074603

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/1996	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
11/26/2001	SUPPL-5	Labeling		Label is not available on this site.
04/05/2001	SUPPL-4	Labeling		Label is not available on this site.
07/15/1999	SUPPL-3	Labeling		Label is not available on this site.
04/14/2000	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/14/2000	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074603

GENERLAC

SOLUTION;ORAL, RECTAL; 10GM/15ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GENERLAC	LACTULOSE	10GM/15ML	SOLUTION;ORAL, RECTAL	Prescription	No	AA	074603	WOCKHARDT BIO AG
LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION;ORAL, RECTAL	Prescription	No	AA	076645	BAJAJ
LACTULOSE	LACTULOSE	10GM/15ML	SOLUTION;ORAL, RECTAL	Prescription	No	AA	090502	FRESENIUS KABI