FDA.report

Application 077091

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL1MGNoNo
002GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL2MGNoNo
003GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL4MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-6575GlimepirideGlimepirideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6576GlimepirideGlimepirideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7523GlimepirideGlimepirideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-217GlimepirideGlimepirideBlenheim Pharmacal, Inc.ANDACurrent
10544-219GlimepirideGlimepirideBlenheim Pharmacal, Inc.ANDACurrent
21695-746GlimepirideGlimepirideRebel Distributors CorpANDACurrent
21695-747GlimepirideGlimepirideRebel Distributors CorpANDACurrent
21695-993GlimepirideGlimepirideRebel Distributors CorpANDACurrent
33261-892GlimepirideGlimepirideAidarex Pharmaceuticals LLCANDACurrent
35356-896GlimepirideGlimepirideLake Erie Medical DBA Quality Care Products LLCANDACurrent
43063-121GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-121GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-121GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-121GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-121GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50268-358GlimepirideGlimepirideAvPAKANDACurrent
50268-358GlimepirideGlimepirideAvPAKANDACurrent
50268-358GlimepirideGlimepirideAvPAKANDACurrent
50268-359GlimepirideGlimepirideAvPAKANDACurrent
50268-359GlimepirideGlimepirideAvPAKANDACurrent
50268-359GlimepirideGlimepirideAvPAKANDACurrent
50268-360GlimepirideGlimepirideAvPAKANDACurrent
50268-360GlimepirideGlimepirideAvPAKANDACurrent
50268-360GlimepirideGlimepirideAvPAKANDACurrent
50436-7073GlimepirideGlimepirideUnit Dose ServicesANDACurrent
50436-7073GlimepirideGlimepirideUnit Dose ServicesANDACurrent
50436-7074GlimepirideGlimepirideUnit Dose ServicesANDACurrent
50436-7075GlimepirideGlimepirideUnit Dose ServicesANDACurrent
54458-966GLIMEPIRIDEGLIMEPIRIDEInternational Laboratories, LLCANDACurrent
54458-967GLIMEPIRIDEGLIMEPIRIDEInternational Laboratories, LLCANDACurrent
55111-320GlimepirideGlimepirideDr. Reddy's Laboratories LimitedANDACurrent
55111-321GlimepirideGlimepirideDr. Reddy's Laboratories LimitedANDACurrent
55111-322GlimepirideGlimepirideDr. Reddy's Laboratories LimitedANDACurrent
55154-8175GlimepirideGlimepirideCardinal HealthANDACurrent
55154-8175GlimepirideGlimepirideCardinal HealthANDACurrent
55154-8175GlimepirideGlimepirideCardinal HealthANDACurrent
55154-8175GlimepirideGlimepirideCardinal HealthANDACurrent
55154-8175GlimepirideGlimepirideCardinal Health 107, LLCANDACurrent
60760-230GLIMEPIRIDEGLIMEPIRIDESt Marys Medical Park PharmacyANDACurrent
60760-230GLIMEPIRIDEGLIMEPIRIDESt Marys Medical Park PharmacyANDACurrent
63629-1255GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
63629-3043GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
63629-3043GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
63629-6309GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
63629-6309GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
63629-6421GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
63629-6421GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
63629-6421GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
63629-6421GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
63629-6930GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
63629-6930GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
63629-6930GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
63629-6930GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
68071-2228GlimepirideGlimepirideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2228GlimepirideGlimepirideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2385GlimepirideGlimepirideNuCare Pharmaceuticals,Inc.ANDACurrent
68084-326GlimepirideGlimepirideAmerican Health PackagingANDACurrent
68084-326GlimepirideGlimepirideAmerican Health PackagingANDACurrent
68084-326GlimepirideGlimepirideAmerican Health PackagingANDACurrent
68084-326GlimepirideGlimepirideAmerican Health PackagingANDACurrent
68084-326GlimepirideGlimepirideAmerican Health PackagingANDACurrent
68084-327GlimepirideGlimepirideAmerican Health PackagingANDACurrent
68084-327GlimepirideGlimepirideAmerican Health PackagingANDACurrent
68084-327GlimepirideGlimepirideAmerican Health PackagingANDACurrent
68084-327GlimepirideGlimepirideAmerican Health PackagingANDACurrent
68084-327GlimepirideGlimepirideAmerican Health PackagingANDACurrent
68084-788GlimepirideGlimepirideAmerican Health PackagingANDACurrent
68084-788GlimepirideGlimepirideAmerican Health PackagingANDACurrent
68084-788GlimepirideGlimepirideAmerican Health PackagingANDACurrent
68084-788GlimepirideGlimepirideAmerican Health PackagingANDACurrent
68084-788GlimepirideGlimepirideAmerican Health PackagingANDACurrent
68645-572GlimepirideGlimepirideLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-572GlimepirideGlimepirideLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-572GlimepirideGlimepirideLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-572GlimepirideGlimepirideLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-573GlimepirideGlimepirideLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-573GlimepirideGlimepirideLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-573GlimepirideGlimepirideLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-573GlimepirideGlimepirideLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-7694GlimepirideGlimepiridePreferred Pharmaceuticals, Inc.ANDACurrent

Documents

DocumentSubmission typeDate
9004ORIG2005-10-11