FDA.reportPublic FDA data

Application 090705

Type
ANDA
Sponsor
INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINCAPSULE;ORAL100MGNoNo
002GABAPENTINGABAPENTINCAPSULE;ORAL300MGNoNo
003GABAPENTINGABAPENTINCAPSULE;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-011GabapentinGabapentinBlenheim Pharmacal, Inc.ANDACurrent
10544-557GabapentinGabapentinBlenheim Pharmacal, Inc.ANDACurrent
31722-221GabapentinGabapentinCamber Pharmaceuticals Inc.ANDACurrent
31722-222GabapentinGabapentinCamber Pharmaceuticals Inc.ANDACurrent
31722-223GabapentinGabapentinCamber Pharmaceuticals Inc.ANDACurrent
35356-727GabapentinGabapentinLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
42254-049GabapentinGabapentinRebel Distributors CorpANDACurrent
43353-709GabapentinGabapentinAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
43353-710GabapentinGabapentinAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
43353-731GabapentinGabapentinAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
45861-011GabapentinGabapentinPharmaceutica North America, Inc.ANDACurrent
45861-100Gabapentin KitGABAPENTINPharmaceutica North America, Inc.ANDACurrent
45865-498GabapentinGabapentinMedsource PharmaceuticalsANDACurrent
45865-498GabapentinGabapentinMedsource PharmaceuticalsANDACurrent
50090-1556GabapentinGabapentinA-S Medication SolutionsANDACurrent
50436-0813GABAPENTINGABAPENTINUnit Dose ServicesANDACurrent
50436-1263GabapentinGabapentinUnit Dose ServicesANDACurrent
50436-7285GabapentinGabapentinUnit Dose ServicesANDACurrent
51655-246GABAPENTINGABAPENTINNorthwind PharmaceuticalsANDACurrent
52959-757GabapentinGabapentinH.J. Harkins Company, Inc.ANDACurrent
53002-1423GABAPENTINGABAPENTINRPK Pharmaceuticals, Inc.ANDACurrent
53002-1423GABAPENTINGABAPENTINRPK Pharmaceuticals, Inc.ANDACurrent
53002-1472GABAPENTINGABAPENTINRPK Pharmaceuticals, Inc.ANDACurrent
53002-1472GABAPENTINGABAPENTINRPK Pharmaceuticals, Inc.ANDACurrent
53002-1472GABAPENTINGABAPENTINRPK Pharmaceuticals, Inc.ANDACurrent
53217-241GABAPENTINGABAPENTINAidarex Pharmaceuticals LLCANDACurrent
55700-453GABAPENTINGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-453GABAPENTINGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-483GABAPENTINGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-483GABAPENTINGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-483GABAPENTINGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-483GABAPENTINGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-039GABAPENTINGABAPENTINSt.Mary's Medical Park PharmacyANDACurrent
60760-627GABAPENTINGABAPENTINSt. MaryANDACurrent
61919-411GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-411GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-417GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-660GABAPENTINGABAPENTINDIRECTRXANDACurrent
61919-660GABAPENTINGABAPENTINDIRECTRXANDACurrent
61919-660GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-660GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-660GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-660GABAPENTINGABAPENTINDirect_RxANDACurrent
61919-982GABAPENTINGABAPENTINDIRECT RXANDACurrent
61919-982GABAPENTINGABAPENTINDIRECT RXANDACurrent
63187-031GabapentinGabapentinProficient Rx LPANDACurrent
63187-031GabapentinGabapentinProficient Rx LPANDACurrent
63187-031GabapentinGabapentinProficient Rx LPANDACurrent
63187-056GabapentinGabapentinProficient Rx LPANDACurrent
63187-056GabapentinGabapentinProficient Rx LPANDACurrent
63187-056GabapentinGabapentinProficient Rx LPANDACurrent
63187-248GabapentinGabapentinProficient Rx LPANDACurrent
63187-248GabapentinGabapentinProficient Rx LPANDACurrent
63187-248GabapentinGabapentinProficient Rx LPANDACurrent
63187-372GABAPENTINGABAPENTINProficient Rx LPANDACurrent
63187-372GABAPENTINGABAPENTINProficient Rx LPANDACurrent
63187-392GABAPENTINGABAPENTINProficient Rx LPANDACurrent
63187-392GABAPENTINGABAPENTINProficient Rx LPANDACurrent
63187-909GABAPENTINGABAPENTINProficient Rx LPANDACurrent
63187-909GABAPENTINGABAPENTINProficient Rx LPANDACurrent
63629-2593GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-3056GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-3056GabapentinGabapentinBryant Ranch PrepackANDACurrent
64205-222GabapentinGabapentinReadyMedsANDACurrent
64725-0221GabapentinGabapentinTYA PharmaceuticalsANDACurrent
64725-0222GabapentinGabapentinTYA PharmaceuticalsANDACurrent
67296-1536GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
67296-1536GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
67296-1536GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
67296-1710GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
67296-1710GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
67296-1721GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
67296-1721GABAPENTINGABAPENTINRedPharm Drug, Inc.ANDACurrent
68071-1212GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1212GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1808GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1907GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3086GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3086GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3086GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.ANDACurrent