Home Applications 077904 Application 077904
Type ANDA
Sponsor CIPLA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 10MG No No 002 PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 20MG No No 003 PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 40MG No No 004 PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 80MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A077904-001 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 A077904-002 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 A077904-003 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 A077904-004 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2016-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 1 of 5 · 172 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 2026-09-14 22:38:34 2026-08 A077904-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077904-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077904-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077904-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2016-03-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077904-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077904-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077904-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077904-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2016-03-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077904-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077904-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077904-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077904-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2016-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077904-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077904-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077904-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077904-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2016-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077904-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077904-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077904-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077904-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2016-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077904-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077904-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077904-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077904-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2016-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077904-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077904-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077904-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077904-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2016-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077904-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077904-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077904-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077904-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2016-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077904-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077904-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077904-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077904-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2016-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077904-001 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077904-002 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077904-003 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077904-004 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2016-03-22 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 7 of 7 · 121 matching rows.
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69097-183 Pravastatin Sodium Pravastatin Sodium Cipla USA Inc. ANDA Current 69097-184 Pravastatin Sodium Pravastatin Sodium Cipla USA Inc. ANDA Current 69097-185 Pravastatin Sodium Pravastatin Sodium Cipla USA Inc. ANDA Current 69097-186 Pravastatin Sodium Pravastatin Sodium Cipla USA Inc. ANDA Current