Home Applications 076980 Application 076980
Type ANDA
Sponsor TEVA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;7.5MG No No 002 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE TABLET;ORAL 25MG;15MG No Yes 003 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE TABLET;ORAL 12.5MG;15MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076980-001 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5MG;7.5MG TABLET / ORAL 2007-03-07 A076980-002 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 25MG;15MG TABLET / ORAL RS 2007-03-07 A076980-003 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5MG;15MG TABLET / ORAL 2007-03-07
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.
Product history page 4 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A076980-001 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 12.5MG;7.5MG TABLET / ORAL AB 2007-03-07 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A076980-002 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL AB RS 2007-03-07 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A076980-003 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 12.5MG;15MG TABLET / ORAL AB 2007-03-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076980-001 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 12.5MG;7.5MG TABLET / ORAL AB 2007-03-07 e64feba35796…2022-09-29 23:25 UTC 2022-09 A076980-002 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL AB RS 2007-03-07 e64feba35796…2022-09-29 23:25 UTC 2022-09 A076980-003 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 12.5MG;15MG TABLET / ORAL AB 2007-03-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076980-001 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 12.5MG;7.5MG TABLET / ORAL AB 2007-03-07 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076980-002 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL AB RS 2007-03-07 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076980-003 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 12.5MG;15MG TABLET / ORAL AB 2007-03-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A076980-001 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 12.5MG;7.5MG TABLET / ORAL 2007-03-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A076980-002 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 25MG;15MG TABLET / ORAL RS 2007-03-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A076980-003 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 12.5MG;15MG TABLET / ORAL 2007-03-07 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0093-5213 Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide Teva Pharmaceuticals USA, Inc. ANDA Current 0093-5214 Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide Teva Pharmaceuticals USA, Inc. ANDA Current 0093-5214 Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide Teva Pharmaceuticals USA, Inc. ANDA Current 0093-5215 Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide Teva Pharmaceuticals USA, Inc. ANDA Current 0093-5215 Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide Teva Pharmaceuticals USA, Inc. ANDA Current 42291-576 Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide AvKARE, Inc. ANDA Current 42291-576 Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide AvKARE, Inc. ANDA Current 42291-577 Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide AvKARE, Inc. ANDA Current 42291-577 Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide AvKARE, Inc. ANDA Current 42291-578 Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide AvKARE, Inc. ANDA Current 42291-578 Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide AvKARE, Inc. ANDA Current