FDA.reportPublic FDA data

Application 211020

Type
ANDA
Sponsor
GRAVITI PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL150MGNoNo
002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-862Bupropion HydrochlorideBupropion HydrochlorideRising Pharma Holdings, Inc.ANDACurrent
16571-863Bupropion HydrochlorideBupropion HydrochlorideRising Pharma Holdings, Inc.ANDACurrent
58657-710Bupropion hydrochlorideBupropion hydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-710Bupropion hydrochlorideBupropion hydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-710Bupropion hydrochlorideBupropion hydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-711Bupropion hydrochlorideBupropion hydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-711Bupropion hydrochlorideBupropion hydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-711Bupropion hydrochlorideBupropion hydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-712Bupropion hydrochlorideBupropion hydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-712Bupropion hydrochlorideBupropion hydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-713Bupropion hydrochlorideBupropion hydrochlorideMethod Pharmaceuticals, LLCANDACurrent
58657-713Bupropion hydrochlorideBupropion hydrochlorideMethod Pharmaceuticals, LLCANDACurrent
68788-8272Bupropion hydrochlorideBupropion hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
69844-010bupropion hydrochlorideextended-releaseGraviti Pharmaceuticals Private LimitedANDACurrent
69844-010BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEGraviti Pharmaceuticals Private LimitedANDACurrent
69844-010bupropion hydrochlorideextended-releaseGraviti Pharmaceuticals Private LimitedANDACurrent
69844-010bupropion hydrochlorideextended-releaseGraviti Pharmaceuticals Private LimitedANDACurrent
69844-011bupropion hydrochlorideextended-releaseGraviti Pharmaceuticals Private LimitedANDACurrent
69844-011bupropion hydrochlorideextended-releaseGraviti Pharmaceuticals Private LimitedANDACurrent
69844-011bupropion hydrochlorideextended-releaseGraviti Pharmaceuticals Private LimitedANDACurrent
69844-011BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEGraviti Pharmaceuticals Private LimitedANDACurrent
69844-064bupropion hydrochlorideextended-releaseGraviti Pharmaceuticals Private LimitedANDACurrent
69844-064bupropion hydrochlorideextended-releaseGraviti Pharmaceuticals Private LimitedANDACurrent
69844-065bupropion hydrochlorideextended-releaseGraviti Pharmaceuticals Private LimitedANDACurrent
69844-065bupropion hydrochlorideextended-releaseGraviti Pharmaceuticals Private LimitedANDACurrent
70377-034bupropion hydrochloridebupropion hydrochlorideBiocon Pharma Inc.,ANDACurrent
70377-034BUPROPION HYDROCHLORIDEbupropion hydrochlorideBiocon Pharma Inc.,ANDACurrent
70377-034BUPROPION HYDROCHLORIDEbupropion hydrochlorideBiocon Pharma Inc.,ANDACurrent
70377-035bupropion hydrochloridebupropion hydrochlorideBiocon Pharma Inc.,ANDACurrent
70377-035BUPROPION HYDROCHLORIDEbupropion hydrochlorideBiocon Pharma Inc.,ANDACurrent
70377-035BUPROPION HYDROCHLORIDEbupropion hydrochlorideBiocon Pharma Inc.,ANDACurrent