Home Applications 070614 Application 070614
Type ANDA
Sponsor PAR PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 METHYLDOPA AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METHYLDOPA TABLET;ORAL 50MG;500MG No No 002 METHYLDOPA AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METHYLDOPA TABLET;ORAL 15MG;250MG No No 003 METHYLDOPA AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METHYLDOPA TABLET;ORAL 25MG;250MG No No 004 METHYLDOPA AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METHYLDOPA TABLET;ORAL 30MG;500MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METHYLDOPA 50MG;500MG TABLET / ORAL 1987-02-02 A070614-002 METHYLDOPA AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METHYLDOPA 15MG;250MG TABLET / ORAL 1987-02-02 A070614-003 METHYLDOPA AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METHYLDOPA 25MG;250MG TABLET / ORAL 1987-02-02 A070614-004 METHYLDOPA AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METHYLDOPA 30MG;500MG TABLET / ORAL 1987-02-02
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 2 of 2 · 59 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 2019-09-15 20:21 UTC 2019-09 A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE 50MG;500MG TABLET / ORAL 1987-02-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE 50MG;500MG TABLET / ORAL 1987-02-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE 50MG;500MG TABLET / ORAL 1987-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE 50MG;500MG TABLET / ORAL 1987-02-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE 50MG;500MG TABLET / ORAL 1987-02-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE 50MG;500MG TABLET / ORAL 1987-02-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE 50MG;500MG TABLET / ORAL 1987-02-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE 50MG;500MG TABLET / ORAL 1987-02-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE 50MG;500MG TABLET / ORAL 1987-02-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE 50MG;500MG TABLET / ORAL 1987-02-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE 50MG;500MG TABLET / ORAL 1987-02-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE 50MG;500MG TABLET / ORAL 1987-02-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE 50MG;500MG TABLET / ORAL 1987-02-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE 50MG;500MG TABLET / ORAL 1987-02-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE 50MG;500MG TABLET / ORAL 1987-02-02 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A070614-001 METHYLDOPA AND HYDROCHLOROTHIAZIDE 50MG;500MG TABLET / ORAL 1987-02-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A070614-002 METHYLDOPA AND HYDROCHLOROTHIAZIDE 15MG;250MG TABLET / ORAL 1987-02-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A070614-003 METHYLDOPA AND HYDROCHLOROTHIAZIDE 25MG;250MG TABLET / ORAL 1987-02-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A070614-004 METHYLDOPA AND HYDROCHLOROTHIAZIDE 30MG;500MG TABLET / ORAL 1987-02-02 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.