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Tri-Sprintec

Tri-Sprintec (norgestimate and ethinyl estradiol tablets - triphasic regimen)PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.Rx only

Approved
Approval ID

7fd4976d-720c-40ee-8723-a703645d4ff0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 6, 2011

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

norgestimate and ethinyl estradiol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-770
Application NumberANDA075808
Product Classification
M
Marketing Category
C73584
G
Generic Name
norgestimate and ethinyl estradiol
Product Specifications
Effective DateOctober 29, 2009
FDA Product Classification

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Tri-Sprintec - FDA Drug Approval Details