FDA.reportPublic FDA data

Application 075135

Type
ANDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PACERONEAMIODARONE HYDROCHLORIDETABLET;ORAL200MGNoNo
002PACERONEAMIODARONE HYDROCHLORIDETABLET;ORAL100MGNoNo
003PACERONEAMIODARONE HYDROCHLORIDETABLET;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0245-0144PaceroneAmiodarone HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-0144PaceroneAmiodarone HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-0147PaceroneAmiodarone HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-0147PaceroneAmiodarone HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0245-1645PaceroneAmiodarone HydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
55154-5606PaceroneAmiodarone HydrochlorideCardinal HealthANDACurrent
55154-5606PaceroneAmiodarone HydrochlorideCardinal HealthANDACurrent
55154-5606PaceroneAmiodarone HydrochlorideCardinal HealthANDACurrent
65084-456PaceroneAmiodarone HydrochlorideMckesson Rxpak IncANDACurrent
67544-570PaceroneAmiodarone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-570PaceroneAmiodarone HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43894ORIG2009-11-20
23758ORIG2005-08-01
42942SUPPL2002-10-29
42941SUPPL2002-10-29
42940SUPPL2002-10-29
22425SUPPL2002-10-29
22424SUPPL2002-10-29
22423SUPPL2002-10-29
22422SUPPL2002-10-29
8533SUPPL2000-02-01
8532SUPPL1999-12-02
30769SUPPL1999-09-24
22421ORIG1999-05-28
39456ORIG1998-04-30
30768SUPPL1998-04-30
30767ORIG1998-04-30