FDA.reportPublic FDA data

Application 050748

Type
NDA
Sponsor
KING PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYNERCIDDALFOPRISTIN; QUINUPRISTININJECTABLE;INTRAVENOUS350MG/VIAL;150MG/VIALYesYes
002SYNERCIDDALFOPRISTIN; QUINUPRISTININJECTABLE;INTRAVENOUS420MG/VIAL;180MG/VIALNoNo

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
N050748-001SYNERCIDDALFOPRISTIN; QUINUPRISTIN350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD1999-09-21
N050748-002SYNERCIDDALFOPRISTIN; QUINUPRISTIN420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24

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 UTC2026-02N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD1999-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD1999-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD1999-09-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD1999-09-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD1999-09-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD1999-09-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD1999-09-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD1999-09-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD1999-09-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050748-001SYNERCID350MG/VIAL;150MG/VIALINJECTABLE / INTRAVENOUSRLD, RS1999-09-21782e0a99824c…
2021-12-28 21:50 UTC2021-12N050748-002SYNERCID420MG/VIAL;180MG/VIALINJECTABLE / INTRAVENOUS2000-08-24782e0a99824c…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61570-260Synercidquinupristin and dalfopristinPfizer Laboratories Div Pfizer IncNDACurrent
61570-260Synercidquinupristin and dalfopristinPfizer Laboratories Div Pfizer IncNDACurrent
61570-260Synercidquinupristin and dalfopristinPfizer Laboratories Div Pfizer IncNDACurrent
61570-260Synercidquinupristin and dalfopristinPfizer Laboratories Div Pfizer IncNDACurrent
61570-260Synercidquinupristin and dalfopristinPfizer Laboratories Div Pfizer IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48777SUPPL2017-06-20
48754SUPPL2017-06-19
39240SUPPL2012-01-25
30434SUPPL2012-01-18
30433SUPPL2010-11-22
8169SUPPL2010-11-22
39239SUPPL2010-11-17
18166SUPPL2010-11-17
8168SUPPL2008-06-20
18165SUPPL2008-06-19
22215ORIG2001-07-18
30432ORIG1999-09-21
18164ORIG1999-09-21