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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075706
Company: P AND L

Products on ANDA 075706

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075706

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/21/2003	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/75706_Loratadine And Pseudoephedrine Sulfate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75706_Loratadine And Pseudoephedrine Sulfate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/075706_loratadine-pseudoephedrine_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/26/2004	SUPPL-6	Labeling		Label is not available on this site.

Labels for ANDA 075706

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/21/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/75706_Loratadine And Pseudoephedrine Sulfate_Prntlbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

LORATADINE AND PSEUDOEPHEDRINE SULFATE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, EXTENDED RELEASE;ORAL; 10MG;240MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CLARITIN-D 24 HOUR	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	Yes	020470	BAYER HEALTHCARE LLC
LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	218017	BIONPHARMA
LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	075706	P AND L
LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	075989	PERRIGO PHARMA INTL
LORATADINE AND PSEUDOEPHEDRINE SULFATE	LORATADINE; PSEUDOEPHEDRINE SULFATE	10MG;240MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	076557	SUN PHARM INDS LTD

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