FDA.report

Application 076004

Type
ANDA
Sponsor
APOTEX INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ETODOLACETODOLACTABLET;ORAL400MGNoNo
002ETODOLACETODOLACTABLET;ORAL500MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-578EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-578EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-578EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-578EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-671EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-671EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-671EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-671EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-671EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-856EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-856EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-856EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-856EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-856EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-856EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-856EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1789EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1789EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1789EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1789EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1789EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1789EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1789EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1790EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1790EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1790EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-1790EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-2133EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-2133EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-2133EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-2133EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-2133EtodolacEtodolacA-S Medication SolutionsANDACurrent
50090-2133EtodolacEtodolacA-S Medication SolutionsANDACurrent
50436-0041EtodolacEtodolacUnit Dose ServicesANDACurrent
53217-362EtodolacEtodolacAidarex Pharmaceuticals LLCANDACurrent
53217-371EtodolacEtodolacAidarex Pharmaceuticals LLCANDACurrent
55700-592EtodolacEtodolacQuality Care Products LLCANDACurrent
55700-592EtodolacEtodolacLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-592EtodolacEtodolacLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-592EtodolacEtodolacLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-592EtodolacEtodolacLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-592EtodolacEtodolacQuality Care Products LLCANDACurrent
55700-592EtodolacEtodolacLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-592EtodolacEtodolacLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-757EtodolacEtodolacQuality Care Products, LLCANDACurrent
55700-757EtodolacEtodolacQuality Care Products, LLCANDACurrent
55700-757EtodolacEtodolacQuality Care Products, LLCANDACurrent
60505-0041EtodolacEtodolacApotex Corp.ANDACurrent
60505-0041EtodolacEtodolacApotex Corp.ANDACurrent
60505-0041EtodolacEtodolacApotex Corp.ANDACurrent
60505-0041EtodolacEtodolacApotex Corp.ANDACurrent
60505-0041EtodolacEtodolacApotex Corp.ANDACurrent
60505-0041EtodolacEtodolacApotex Corp.ANDACurrent
60505-0102EtodolacEtodolacApotex Corp.ANDACurrent
60505-0102EtodolacEtodolacApotex Corp.ANDACurrent
60505-0102EtodolacEtodolacApotex Corp.ANDACurrent
60505-0102EtodolacEtodolacApotex Corp.ANDACurrent
60505-0102EtodolacEtodolacApotex Corp.ANDACurrent
60505-0102EtodolacEtodolacApotex Corp.ANDACurrent
60760-552EtodolacEtodolacSt. MaryANDACurrent
60760-552EtodolacEtodolacSt. MaryANDACurrent
60760-552EtodolacEtodolacSt. MaryANDACurrent
61919-251ETODOLACETODOLACDIRECT RXANDACurrent
61919-251ETODOLACETODOLACDIRECT RXANDACurrent
61919-251ETODOLACETODOLACDIRECT RXANDACurrent
61919-784ETODOLACETODOLACDIRECT RXANDACurrent
61919-784ETODOLACETODOLACDIRECT RXANDACurrent
61919-858ETODOLACETODOLACDIRECT RXANDACurrent
63187-736EtodolacEtodolacProficient Rx LPANDACurrent
63187-736EtodolacEtodolacProficient Rx LPANDACurrent
63187-736EtodolacEtodolacProficient Rx LPANDACurrent
63629-8805EtodolacEtodolacBryant Ranch PrepackANDACurrent
63629-8805EtodolacEtodolacBryant Ranch PrepackANDACurrent
66267-095EtodolacEtodolacNuCare Pharmaceuticals, Inc.ANDACurrent
66267-095EtodolacEtodolacNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6901EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-6901EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-9410EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-9410EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-9410EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent