FDA.reportPublic FDA data

Application 079017

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL18MGNoNo
002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL25MGNoNo
003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL40MGNoNo
004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL60MGNoNo
005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL80MGNoNo
006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL100MGNoNo
007ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079017-001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2010-09-16
A079017-002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2010-09-16
A079017-003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2010-09-16
A079017-004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2010-09-16
A079017-005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2010-09-16
A079017-006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2010-09-16
A079017-007ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2023-04-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A079017-001AB
A079017-002AB
A079017-003AB
A079017-004AB
A079017-005AB
A079017-006AB
A079017-007AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A079017-001ATOMOXETINE HYDROCHLORIDEEQ 18MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-002ATOMOXETINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-003ATOMOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-004ATOMOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-005ATOMOXETINE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-006ATOMOXETINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2010-09-16a50c72e98297…
2026-08-01 22:54:322026-06A079017-007ATOMOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2023-04-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A079017-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A079017-007AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
atomoxetineATOMOXETINEZydus Pharmaceuticals USA Inc.5f89c7c9-4c25-4ba2-ad90-5aeadb48f2142025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079017
application number: ANDA079017
ndc (product): 68382-218
ndc (product): 68382-216
ndc (product): 68382-223
ndc (product): 68382-217
ndc (product): 68382-220
ndc (product): 68382-219

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65841-606atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-606atomoxetineatomoxetineZydus Lifesciences LimitedANDACurrent
65841-606atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-606atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-607atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-607atomoxetineatomoxetineZydus Lifesciences LimitedANDACurrent
65841-607atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-607atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-608atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-608atomoxetineatomoxetineZydus Lifesciences LimitedANDACurrent
65841-608atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-608atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-609atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-609atomoxetineatomoxetineZydus Lifesciences LimitedANDACurrent
65841-609atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-609atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-610atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-610atomoxetineatomoxetineZydus Lifesciences LimitedANDACurrent
65841-610atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-610atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-611atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-611atomoxetineatomoxetineZydus Lifesciences LimitedANDACurrent
65841-611atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
65841-611atomoxetineatomoxetineCadila Healthcare LimitedANDACurrent
68382-216atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-216atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-216atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-216atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-217atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-217atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-217atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-217atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-218atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-218atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-218atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-218atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-219atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-219atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-219atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-219atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-220atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-220atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-220atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-220atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-223atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-223atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-223atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-223atomoxetineatomoxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent