Application 062372

Type
ANDA
Sponsor
BAYER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEZLINMEZLOCILLIN SODIUM MONOHYDRATEINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo
002MEZLINMEZLOCILLIN SODIUM MONOHYDRATEINJECTABLE;INJECTIONEQ 3GM BASE/VIALNoNo
003MEZLINMEZLOCILLIN SODIUM MONOHYDRATEINJECTABLE;INJECTIONEQ 4GM BASE/VIALNoNo
004MEZLINMEZLOCILLIN SODIUM MONOHYDRATEINJECTABLE;INJECTIONEQ 20GM BASE/VIALNoNo
005MEZLINMEZLOCILLIN SODIUM MONOHYDRATEINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A062372-001MEZLINMEZLOCILLIN SODIUM MONOHYDRATEEQ 2GM BASE/VIALINJECTABLE / INJECTION1982-05-13
A062372-002MEZLINMEZLOCILLIN SODIUM MONOHYDRATEEQ 3GM BASE/VIALINJECTABLE / INJECTION1982-05-13
A062372-003MEZLINMEZLOCILLIN SODIUM MONOHYDRATEEQ 4GM BASE/VIALINJECTABLE / INJECTION1982-05-13
A062372-004MEZLINMEZLOCILLIN SODIUM MONOHYDRATEEQ 20GM BASE/VIALINJECTABLE / INJECTION1988-03-02
A062372-005MEZLINMEZLOCILLIN SODIUM MONOHYDRATEEQ 1GM BASE/VIALINJECTABLE / INJECTION1983-01-13

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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A062372-001MEZLINEQ 2GM BASE/VIALINJECTABLE / INJECTION1982-05-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062372-002MEZLINEQ 3GM BASE/VIALINJECTABLE / INJECTION1982-05-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062372-003MEZLINEQ 4GM BASE/VIALINJECTABLE / INJECTION1982-05-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062372-004MEZLINEQ 20GM BASE/VIALINJECTABLE / INJECTION1988-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062372-005MEZLINEQ 1GM BASE/VIALINJECTABLE / INJECTION1983-01-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062372-001MEZLINEQ 2GM BASE/VIALINJECTABLE / INJECTION1982-05-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062372-002MEZLINEQ 3GM BASE/VIALINJECTABLE / INJECTION1982-05-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062372-003MEZLINEQ 4GM BASE/VIALINJECTABLE / INJECTION1982-05-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062372-004MEZLINEQ 20GM BASE/VIALINJECTABLE / INJECTION1988-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062372-005MEZLINEQ 1GM BASE/VIALINJECTABLE / INJECTION1983-01-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A062372-001MEZLINEQ 2GM BASE/VIALINJECTABLE / INJECTION1982-05-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062372-002MEZLINEQ 3GM BASE/VIALINJECTABLE / INJECTION1982-05-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062372-003MEZLINEQ 4GM BASE/VIALINJECTABLE / INJECTION1982-05-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062372-004MEZLINEQ 20GM BASE/VIALINJECTABLE / INJECTION1988-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062372-005MEZLINEQ 1GM BASE/VIALINJECTABLE / INJECTION1983-01-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062372-001MEZLINEQ 2GM BASE/VIALINJECTABLE / INJECTION1982-05-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062372-002MEZLINEQ 3GM BASE/VIALINJECTABLE / INJECTION1982-05-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062372-003MEZLINEQ 4GM BASE/VIALINJECTABLE / INJECTION1982-05-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062372-004MEZLINEQ 20GM BASE/VIALINJECTABLE / INJECTION1988-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062372-005MEZLINEQ 1GM BASE/VIALINJECTABLE / INJECTION1983-01-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062372-001MEZLINEQ 2GM BASE/VIALINJECTABLE / INJECTION1982-05-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062372-002MEZLINEQ 3GM BASE/VIALINJECTABLE / INJECTION1982-05-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062372-003MEZLINEQ 4GM BASE/VIALINJECTABLE / INJECTION1982-05-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062372-004MEZLINEQ 20GM BASE/VIALINJECTABLE / INJECTION1988-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062372-005MEZLINEQ 1GM BASE/VIALINJECTABLE / INJECTION1983-01-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062372-001MEZLINEQ 2GM BASE/VIALINJECTABLE / INJECTION1982-05-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062372-002MEZLINEQ 3GM BASE/VIALINJECTABLE / INJECTION1982-05-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062372-003MEZLINEQ 4GM BASE/VIALINJECTABLE / INJECTION1982-05-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062372-004MEZLINEQ 20GM BASE/VIALINJECTABLE / INJECTION1988-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062372-005MEZLINEQ 1GM BASE/VIALINJECTABLE / INJECTION1983-01-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062372-001MEZLINEQ 2GM BASE/VIALINJECTABLE / INJECTION1982-05-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062372-002MEZLINEQ 3GM BASE/VIALINJECTABLE / INJECTION1982-05-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062372-003MEZLINEQ 4GM BASE/VIALINJECTABLE / INJECTION1982-05-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062372-004MEZLINEQ 20GM BASE/VIALINJECTABLE / INJECTION1988-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062372-005MEZLINEQ 1GM BASE/VIALINJECTABLE / INJECTION1983-01-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062372-001MEZLINEQ 2GM BASE/VIALINJECTABLE / INJECTION1982-05-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062372-002MEZLINEQ 3GM BASE/VIALINJECTABLE / INJECTION1982-05-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062372-003MEZLINEQ 4GM BASE/VIALINJECTABLE / INJECTION1982-05-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062372-004MEZLINEQ 20GM BASE/VIALINJECTABLE / INJECTION1988-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062372-005MEZLINEQ 1GM BASE/VIALINJECTABLE / INJECTION1983-01-135bbf6a4d5a75…