FDA.report

Application 207342

Type
ANDA
Sponsor
AMNEAL PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASE;ORAL600MGNoNo
002GUAIFENESINGUAIFENESINTABLET, EXTENDED RELEASE;ORAL1.2GMNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0832Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0363-0832Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0363-0832Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0363-0832Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0363-0931Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0363-0931Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0363-0931Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0363-0931Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0363-0931Mucus Relief Extended ReleaseGuaifenesinWalgreensANDACurrent
0536-1163Mucus Relief Extended ReleaseGuaifenesinRugby Laboratories, Inc.ANDACurrent
0536-1163Mucus Relief Extended ReleaseGuaifenesinRugby Laboratories, Inc.ANDACurrent
0536-1163Mucus Relief Extended ReleaseGuaifenesinRugby Laboratories, Inc.ANDACurrent
0904-6718Mucus Relief Extended ReleaseGuaifenesinMajor PharmaceuticalsANDACurrent
0904-6718Mucus Relief Extended ReleaseGuaifenesinMajor PharmaceuticalsANDACurrent
0904-6718Mucus Relief Extended ReleaseGuaifenesinMajor PharmaceuticalsANDACurrent
11673-731Mucus Relief Extended-ReleaseGuaifenesinTARGET CorporationANDACurrent
11673-731Mucus Relief Extended-ReleaseGuaifenesinTARGET CorporationANDACurrent
11673-731Mucus Relief Extended-ReleaseGuaifenesinTARGET CorporationANDACurrent
11673-732Mucus Relief Extended ReleaseGuaifenesinTARGET CorporationANDACurrent
11673-732Mucus Relief Extended ReleaseGuaifenesinTARGET CorporationANDACurrent
11673-732Mucus Relief Extended ReleaseGuaifenesinTARGET CorporationANDACurrent
11822-0731Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-0731Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-0732Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-0732Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-0732Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-2252Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-2252Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-3252Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-7329Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
11822-7329Mucus ReliefGuaifenesinRite Aid CorporationANDACurrent
36800-137Mucus ReliefGuaifenesinTOP CARE (Topco Associates LLC)ANDACurrent
36800-137Mucus ReliefGuaifenesinTOP CARE (Topco Associates LLC)ANDACurrent
36800-137Mucus ReliefGuaifenesinTOP CARE (Topco Associates LLC)ANDACurrent
36800-137Mucus ReliefGuaifenesinTOP CARE (Topco Associates LLC)ANDACurrent
36800-932Mucus ReliefGuaifenesinTOP CARE (Topco Associates LLC)ANDACurrent
36800-932Mucus ReliefGuaifenesinTOP CARE (Topco Associates LLC)ANDACurrent
36800-932Mucus ReliefGuaifenesinTOP CARE (Topco Associates LLC)ANDACurrent
36800-932Mucus ReliefGuaifenesinTOP CARE (Topco Associates LLC)ANDACurrent
37012-727Mucus ReliefGuaifenesinShopko Stores Operating Co., LLC.ANDACurrent
37012-727Mucus ReliefGuaifenesinShopko Stores Operating Co., LLC.ANDACurrent
37012-727Mucus ReliefGuaifenesinShopko Stores Operating Co., LLC.ANDACurrent
37012-728Mucus ReliefGuaifenesinShopko Stores Operating Co., LLC.ANDACurrent
37012-728Mucus ReliefGuaifenesinShopko Stores Operating Co., LLC.ANDACurrent
37012-728Mucus ReliefGuaifenesinShopko Stores Operating Co., LLC.ANDACurrent
37808-762Mucus Relief Extended ReleaseGuaifenesinH E BANDACurrent
37808-762Mucus Relief Extended ReleaseGuaifenesinH E BANDACurrent
37808-762Mucus Relief Extended ReleaseGuaifenesinH E BANDACurrent
37808-935Mucus ReliefGuaifenesinH E BANDACurrent
37808-935Mucus ReliefGuaifenesinH E BANDACurrent
41163-731Mucus ReliefGuaifenesinEQUALINE (SuperValu)ANDACurrent
41163-731Mucus ReliefGuaifenesinEQUALINE (SuperValu)ANDACurrent
41163-731Mucus ReliefGuaifenesinEQUALINE (SuperValu)ANDACurrent
41250-732Mucus Relief Extended ReleaseGuaifenesinMEIJER, INC.ANDACurrent
41250-732Mucus Relief Extended ReleaseGuaifenesinMEIJER, INC.ANDACurrent
41520-731Mucus Relief Extended ReleaseGuaifenesinCare One (American Sales Company)ANDACurrent
41520-731Mucus Relief Extended ReleaseGuaifenesinCare One (American Sales Company)ANDACurrent
41520-731Mucus Relief Extended ReleaseGuaifenesinCare One (American Sales Company)ANDACurrent
41520-732Mucus ReliefGuaifenesinCare One (American Sales Company)ANDACurrent
41520-732Mucus ReliefGuaifenesinCare One (American Sales Company)ANDACurrent
41520-732Mucus ReliefGuaifenesinCare One (American Sales Company)ANDACurrent
55154-4153Mucus Relief Extended ReleaseGuaifenesinCardinal Health 107, LLCANDACurrent
55315-732Mucus Relief Extended ReleaseGuaifenesinFreds IncANDACurrent
55315-732Mucus Relief Extended ReleaseGuaifenesinFreds IncANDACurrent
55319-732Mucus Relief Extended ReleaseGuaifenesinFamily Dollar (FAMILY WELLNESS)ANDACurrent
55319-732Mucus Relief Extended ReleaseGuaifenesinFamily Dollar (FAMILY WELLNESS)ANDACurrent
55910-732Mucus ReliefGuaifenesinDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-732Mucus ReliefGuaifenesinDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-732Mucus ReliefGuaifenesinDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-732Mucus ReliefGuaifenesinDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-739Mucus ReliefGuaifenesinDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-739Mucus ReliefGuaifenesinDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-739Mucus ReliefGuaifenesinDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-739Mucus ReliefGuaifenesinDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
59726-831Mucus ReliefGuaifenesinP & L Development, LLCANDACurrent
59726-831Mucus ReliefGuaifenesinP & L Development, LLCANDACurrent
59726-832Mucus ReliefGuaifenesinP & L Development, LLCANDACurrent
59726-832Mucus ReliefGuaifenesinP & L Development, LLCANDACurrent
62011-0377Mucus Relief Extended ReleaseGuaifenesinStrategic Sourcing Services LLCANDACurrent
62011-0377Mucus Relief Extended ReleaseGuaifenesinStrategic Sourcing Services LLCANDACurrent