NDC 59651-494

ambrisentan

Ambrisentan

ambrisentan is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Ambrisentan.

Product ID59651-494_82e51c75-fb78-4ad3-8bce-5e0581d60014
NDC59651-494
Product TypeHuman Prescription Drug
Proprietary Nameambrisentan
Generic NameAmbrisentan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2022-07-21
Marketing CategoryANDA /
Application NumberANDA216531
Labeler NameAurobindo Pharma Limited
Substance NameAMBRISENTAN
Active Ingredient Strength5 mg/1
Pharm ClassesEndothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 59651-494-30

30 TABLET, FILM COATED in 1 BOTTLE (59651-494-30)
Marketing Start Date2022-07-21
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "ambrisentan" or generic name "Ambrisentan"

NDCBrand NameGeneric Name
0378-4270Ambrisentanambrisentan
0378-4271Ambrisentanambrisentan
0591-2405AmbrisentanAmbrisentan
0591-2406AmbrisentanAmbrisentan
42291-018AMBRISENTANAMBRISENTAN
42291-019AMBRISENTANAMBRISENTAN
42794-051AMBRISENTANAMBRISENTAN
42794-052AMBRISENTANAMBRISENTAN
47335-236ambrisentanambrisentan
47335-237ambrisentanambrisentan
49884-353AmbrisentanAmbrisentan
49884-354AmbrisentanAmbrisentan
59651-494ambrisentanambrisentan
59651-495ambrisentanambrisentan
60505-4552AmbrisentanAMBRISENTAN
60505-4553AmbrisentanAMBRISENTAN
69097-386AmbrisentanAmbrisentan
69097-387AmbrisentanAmbrisentan
70710-1179AmbrisentanAmbrisentan
70710-1180AmbrisentanAmbrisentan
70771-1363AmbrisentanAmbrisentan
70771-1364AmbrisentanAmbrisentan
76282-684AmbrisentanAmbrisentan
76282-685AmbrisentanAmbrisentan
61958-0801LetairisAMBRISENTAN
61958-0802LetairisAMBRISENTAN

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