Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040164
Company: RISING

Products on ANDA 040164

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AKPENTOLATE	CYCLOPENTOLATE HYDROCHLORIDE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040164

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/13/1997	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
07/19/2017	SUPPL-8	Labeling-Container/Carton Labels		Label is not available on this site.
07/25/2012	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
04/13/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/09/2001	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
10/09/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
07/11/2001	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.
06/07/1999	SUPPL-1	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.

Therapeutic Equivalents for ANDA 040164

AKPENTOLATE

SOLUTION/DROPS;OPHTHALMIC; 1%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AKPENTOLATE	CYCLOPENTOLATE HYDROCHLORIDE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	040164	RISING
CYCLOGYL	CYCLOPENTOLATE HYDROCHLORIDE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	084110	ALCON LABS INC
PENTOLAIR	CYCLOPENTOLATE HYDROCHLORIDE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	040075	BAUSCH AND LOMB