Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070690
Company: HIKMA

Products on ANDA 070690

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION;ORAL	Prescription	None	No	Yes
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070690

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/1987	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
06/16/2017	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
09/10/2008	SUPPL-20	Labeling		Label is not available on this site.
07/09/2008	SUPPL-19	Labeling		Label is not available on this site.
06/21/2007	SUPPL-17	Labeling		Label is not available on this site.
06/09/2004	SUPPL-14	Labeling		Label is not available on this site.
08/01/2001	SUPPL-13	Labeling		Label is not available on this site.
10/23/1998	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/12/1999	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
08/28/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/05/1994	SUPPL-8	Labeling		Label is not available on this site.
05/16/1991	SUPPL-7	Labeling		Label is not available on this site.
10/09/1990	SUPPL-6	Labeling		Label is not available on this site.
04/04/1990	SUPPL-5	Labeling		Label is not available on this site.
09/25/1989	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/24/1989	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
01/24/1989	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
01/08/1990	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 070690

PROPRANOLOL HYDROCHLORIDE

SOLUTION;ORAL; 20MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION;ORAL	Prescription	No	AA	070690	HIKMA
PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION;ORAL	Prescription	No	AA	219165	PAI HOLDINGS