Application 061976

Type
ANDA
Sponsor
APOTHECON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VELOSEFCEPHRADINEINJECTABLE;INJECTION250MG/VIALNoNo
002VELOSEFCEPHRADINEINJECTABLE;INJECTION500MG/VIALNoNo
003VELOSEFCEPHRADINEINJECTABLE;INJECTION2GM/VIALNoNo
004VELOSEFCEPHRADINEINJECTABLE;INJECTION1GM/VIALNoNo
005VELOSEFCEPHRADINEINJECTABLE;INJECTION4GM/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A061976-001VELOSEFCEPHRADINE250MG/VIALINJECTABLE / INJECTIONApproved before 1982
A061976-002VELOSEFCEPHRADINE500MG/VIALINJECTABLE / INJECTIONApproved before 1982
A061976-003VELOSEFCEPHRADINE2GM/VIALINJECTABLE / INJECTIONApproved before 1982
A061976-004VELOSEFCEPHRADINE1GM/VIALINJECTABLE / INJECTIONApproved before 1982
A061976-005VELOSEFCEPHRADINE4GM/VIALINJECTABLE / INJECTIONApproved before 1982

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A061976-001VELOSEF250MG/VIALINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08A061976-002VELOSEF500MG/VIALINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08A061976-003VELOSEF2GM/VIALINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08A061976-004VELOSEF1GM/VIALINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08A061976-005VELOSEF4GM/VIALINJECTABLE / INJECTIONApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07A061976-001VELOSEF250MG/VIALINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A061976-002VELOSEF500MG/VIALINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A061976-003VELOSEF2GM/VIALINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A061976-004VELOSEF1GM/VIALINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A061976-005VELOSEF4GM/VIALINJECTABLE / INJECTIONApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A061976-001VELOSEF250MG/VIALINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061976-002VELOSEF500MG/VIALINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061976-003VELOSEF2GM/VIALINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061976-004VELOSEF1GM/VIALINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061976-005VELOSEF4GM/VIALINJECTABLE / INJECTIONApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061976-001VELOSEF250MG/VIALINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061976-002VELOSEF500MG/VIALINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061976-003VELOSEF2GM/VIALINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061976-004VELOSEF1GM/VIALINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061976-005VELOSEF4GM/VIALINJECTABLE / INJECTIONApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A061976-001VELOSEF250MG/VIALINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061976-002VELOSEF500MG/VIALINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061976-003VELOSEF2GM/VIALINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061976-004VELOSEF1GM/VIALINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061976-005VELOSEF4GM/VIALINJECTABLE / INJECTIONApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061976-001VELOSEF250MG/VIALINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061976-002VELOSEF500MG/VIALINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061976-003VELOSEF2GM/VIALINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061976-004VELOSEF1GM/VIALINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061976-005VELOSEF4GM/VIALINJECTABLE / INJECTIONApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061976-001VELOSEF250MG/VIALINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061976-002VELOSEF500MG/VIALINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061976-003VELOSEF2GM/VIALINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061976-004VELOSEF1GM/VIALINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061976-005VELOSEF4GM/VIALINJECTABLE / INJECTIONApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061976-001VELOSEF250MG/VIALINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061976-002VELOSEF500MG/VIALINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061976-003VELOSEF2GM/VIALINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061976-004VELOSEF1GM/VIALINJECTABLE / INJECTIONApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061976-005VELOSEF4GM/VIALINJECTABLE / INJECTIONApproved before 198203ed91905a0d…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.