Home Applications 075328 Application 075328
Type ANDA
Sponsor VINTAGE PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PEMOLINE PEMOLINE TABLET;ORAL 18.75MG No No 002 PEMOLINE PEMOLINE TABLET;ORAL 37.5MG No No 003 PEMOLINE PEMOLINE TABLET;ORAL 75MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A075328-001 PEMOLINE PEMOLINE 18.75MG TABLET / ORAL 2000-04-19 A075328-002 PEMOLINE PEMOLINE 37.5MG TABLET / ORAL 2000-04-19 A075328-003 PEMOLINE PEMOLINE 75MG TABLET / ORAL 2000-04-19
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 4 · 129 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 A075328-001 PEMOLINE 18.75MG TABLET / ORAL 2000-04-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075328-002 PEMOLINE 37.5MG TABLET / ORAL 2000-04-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075328-003 PEMOLINE 75MG TABLET / ORAL 2000-04-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075328-001 PEMOLINE 18.75MG TABLET / ORAL 2000-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075328-002 PEMOLINE 37.5MG TABLET / ORAL 2000-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075328-003 PEMOLINE 75MG TABLET / ORAL 2000-04-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075328-001 PEMOLINE 18.75MG TABLET / ORAL 2000-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075328-002 PEMOLINE 37.5MG TABLET / ORAL 2000-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075328-003 PEMOLINE 75MG TABLET / ORAL 2000-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075328-001 PEMOLINE 18.75MG TABLET / ORAL 2000-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075328-002 PEMOLINE 37.5MG TABLET / ORAL 2000-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075328-003 PEMOLINE 75MG TABLET / ORAL 2000-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075328-001 PEMOLINE 18.75MG TABLET / ORAL 2000-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075328-002 PEMOLINE 37.5MG TABLET / ORAL 2000-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075328-003 PEMOLINE 75MG TABLET / ORAL 2000-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075328-001 PEMOLINE 18.75MG TABLET / ORAL 2000-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075328-002 PEMOLINE 37.5MG TABLET / ORAL 2000-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075328-003 PEMOLINE 75MG TABLET / ORAL 2000-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075328-001 PEMOLINE 18.75MG TABLET / ORAL 2000-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075328-002 PEMOLINE 37.5MG TABLET / ORAL 2000-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075328-003 PEMOLINE 75MG TABLET / ORAL 2000-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075328-001 PEMOLINE 18.75MG TABLET / ORAL 2000-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075328-002 PEMOLINE 37.5MG TABLET / ORAL 2000-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075328-003 PEMOLINE 75MG TABLET / ORAL 2000-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075328-001 PEMOLINE 18.75MG TABLET / ORAL 2000-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075328-002 PEMOLINE 37.5MG TABLET / ORAL 2000-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075328-003 PEMOLINE 75MG TABLET / ORAL 2000-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075328-001 PEMOLINE 18.75MG TABLET / ORAL 2000-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075328-002 PEMOLINE 37.5MG TABLET / ORAL 2000-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075328-003 PEMOLINE 75MG TABLET / ORAL 2000-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075328-001 PEMOLINE 18.75MG TABLET / ORAL 2000-04-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075328-002 PEMOLINE 37.5MG TABLET / ORAL 2000-04-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075328-003 PEMOLINE 75MG TABLET / ORAL 2000-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075328-001 PEMOLINE 18.75MG TABLET / ORAL 2000-04-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075328-002 PEMOLINE 37.5MG TABLET / ORAL 2000-04-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075328-003 PEMOLINE 75MG TABLET / ORAL 2000-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075328-001 PEMOLINE 18.75MG TABLET / ORAL 2000-04-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075328-002 PEMOLINE 37.5MG TABLET / ORAL 2000-04-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075328-003 PEMOLINE 75MG TABLET / ORAL 2000-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075328-001 PEMOLINE 18.75MG TABLET / ORAL 2000-04-19 301d65b070ca…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 30852 ORIG 2000-04-19