Application 050668

Type
NDA
Sponsor
KING PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORABIDLORACARBEFCAPSULE;ORAL200MGNoNo
002LORABIDLORACARBEFCAPSULE;ORAL400MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050668-001LORABIDLORACARBEF200MGCAPSULE / ORAL1991-12-31
N050668-002LORABIDLORACARBEF400MGCAPSULE / ORAL1996-04-05

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050668-001LORABID200MGCAPSULE / ORAL1991-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050668-002LORABID400MGCAPSULE / ORAL1996-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050668-001LORABID200MGCAPSULE / ORAL1991-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050668-002LORABID400MGCAPSULE / ORAL1996-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N050668-001LORABID200MGCAPSULE / ORAL1991-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050668-002LORABID400MGCAPSULE / ORAL1996-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050668-001LORABID200MGCAPSULE / ORAL1991-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050668-002LORABID400MGCAPSULE / ORAL1996-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050668-001LORABID200MGCAPSULE / ORAL1991-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050668-002LORABID400MGCAPSULE / ORAL1996-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050668-001LORABID200MGCAPSULE / ORAL1991-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050668-002LORABID400MGCAPSULE / ORAL1996-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050668-001LORABID200MGCAPSULE / ORAL1991-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050668-002LORABID400MGCAPSULE / ORAL1996-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050668-001LORABID200MGCAPSULE / ORAL1991-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050668-002LORABID400MGCAPSULE / ORAL1996-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050668-001LORABID200MGCAPSULE / ORAL1991-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050668-002LORABID400MGCAPSULE / ORAL1996-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050668-001LORABID200MGCAPSULE / ORAL1991-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N050668-002LORABID400MGCAPSULE / ORAL1996-04-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050668-001LORABID200MGCAPSULE / ORAL1991-12-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050668-002LORABID400MGCAPSULE / ORAL1996-04-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050668-001LORABID200MGCAPSULE / ORAL1991-12-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050668-002LORABID400MGCAPSULE / ORAL1996-04-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050668-001LORABID200MGCAPSULE / ORAL1991-12-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050668-002LORABID400MGCAPSULE / ORAL1996-04-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050668-001LORABID200MGCAPSULE / ORAL1991-12-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050668-002LORABID400MGCAPSULE / ORAL1996-04-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050668-001LORABID200MGCAPSULE / ORAL1991-12-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050668-002LORABID400MGCAPSULE / ORAL1996-04-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050668-001LORABID200MGCAPSULE / ORAL1991-12-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050668-002LORABID400MGCAPSULE / ORAL1996-04-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050668-001LORABID200MGCAPSULE / ORAL1991-12-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050668-002LORABID400MGCAPSULE / ORAL1996-04-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050668-001LORABID200MGCAPSULE / ORAL1991-12-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050668-002LORABID400MGCAPSULE / ORAL1996-04-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050668-001LORABID200MGCAPSULE / ORAL1991-12-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050668-002LORABID400MGCAPSULE / ORAL1996-04-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050668-001LORABID200MGCAPSULE / ORAL1991-12-31782e0a99824c…
2021-12-28 21:50 UTC2021-12N050668-002LORABID400MGCAPSULE / ORAL1996-04-05782e0a99824c…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42669SUPPL1997-11-04