FDA.reportPublic FDA data

Application 211586

Type
ANDA
Sponsor
AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPRENORPHINEBUPRENORPHINEFILM, EXTENDED RELEASE;TRANSDERMAL5MCG/HRNoNo
002BUPRENORPHINEBUPRENORPHINEFILM, EXTENDED RELEASE;TRANSDERMAL7.5MCG/HRNoNo
003BUPRENORPHINEBUPRENORPHINEFILM, EXTENDED RELEASE;TRANSDERMAL10MCG/HRNoNo
004BUPRENORPHINEBUPRENORPHINEFILM, EXTENDED RELEASE;TRANSDERMAL15MCG/HRNoNo
005BUPRENORPHINEBUPRENORPHINEFILM, EXTENDED RELEASE;TRANSDERMAL20MCG/HRNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1202BuprenorphineBuprenorphineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1202BuprenorphineBuprenorphineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1202BuprenorphineBuprenorphineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1203BuprenorphineBuprenorphineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1203BuprenorphineBuprenorphineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1203BuprenorphineBuprenorphineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1204BuprenorphineBuprenorphineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1204BuprenorphineBuprenorphineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1204BuprenorphineBuprenorphineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1205BuprenorphineBuprenorphineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1205BuprenorphineBuprenorphineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1205BuprenorphineBuprenorphineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1505BuprenorphineBuprenorphineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1505BuprenorphineBuprenorphineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1505BuprenorphineBuprenorphineAmneal Pharmaceuticals NY LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76456ORIG 2023-11-07
63098ORIG2020-05-19