Application 203458

Type
ANDA
Sponsor
UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METRONIDAZOLEMETRONIDAZOLETABLET;ORAL250MGNoNo
002METRONIDAZOLEMETRONIDAZOLETABLET;ORAL500MGNoNo

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

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
A203458-001METRONIDAZOLEMETRONIDAZOLE250MGTABLET / ORALAB2014-01-22
A203458-002METRONIDAZOLEMETRONIDAZOLE500MGTABLET / ORALAB2014-01-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203458-001AB
A203458-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-2284e616aacf4f…
2026-09-14 22:38:342026-08A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-2284e616aacf4f…
2026-08-18 06:07:402026-07A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-22caaa826d4ba7…
2026-08-18 06:07:402026-07A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203458-001METRONIDAZOLE250MGTABLET / ORALAB2014-01-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203458-002METRONIDAZOLE500MGTABLET / ORALAB2014-01-2274a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203458-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203458-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A203458-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203458-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203458-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203458-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203458-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203458-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203458-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203458-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203458-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203458-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203458-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203458-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203458-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203458-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203458-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203458-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203458-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203458-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203458-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203458-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203458-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203458-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203458-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203458-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203458-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203458-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203458-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203458-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203458-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203458-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203458-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203458-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203458-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203458-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203458-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203458-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203458-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203458-002AB174a2ff9319b5…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLEPD-Rx Pharmaceuticals, Inc.4cdd7ac5-a52c-4766-afeb-1b5e567a328c2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack1abb2827-67e4-43c0-9762-8261f480fc3a2025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLENuCare Pharmaceuticals,Inc.b1d13c9f-cf8e-4646-e053-2a95a90a4a352025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLENuCare Pharmaceuticals, Inc.4ab90d8e-c21f-65ac-e054-00144ff8d46c2025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEQuality Care Products LLC0d8125d6-173f-4498-85a9-a1323c7a0e422024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
ndc (product): 55700-298
MetronidazoleMETRONIDAZOLEBryant Ranch Prepackdaee5e69-aa86-470b-81b7-3074d27fc8472024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack8e1f507b-22fa-4033-9b3e-5435f20ace662024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEBryant Ranch Prepackcdd942a1-fb3b-4912-bd3f-8aef451e6a3c2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
MetronidazoleMETRONIDAZOLEUnichem Pharmaceuticals (USA), Inc.9219588b-0a99-40b9-bdd4-ced6d6efebed2024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
ndc (product): 29300-226
ndc (product): 29300-227
MetronidazoleMETRONIDAZOLEPharmPak, Inc.be23affb-5b30-40ee-b0b5-829666bafaeb2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
ndc (product): 54348-740
MetronidazoleMETRONIDAZOLEPharmPak, Inc.6a77b5b6-3199-4526-bd68-2e511353d7c62022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203458
application number: ANDA203458
ndc (product): 54348-745

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 174 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12634-172MetronidazoleMetronidazoleApotheca Inc.ANDACurrent
29300-226MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-226MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-226MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-226MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-226MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-226MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-227MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-227MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-227MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-227MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-227MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-227MetronidazoleMetronidazoleUnichem Pharmaceuticals (USA), Inc.ANDACurrent
43063-719MetronidazoleMetronidazolePD-Rx Pharmaceuticals, InANDACurrent
43063-719MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-719MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-719MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-719MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-719MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-719MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-738MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-738MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-738MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-738MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-738MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-738MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-717MetronidazoleMetronidazolemedsource pharmaceuticalsANDACurrent
50090-0201MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0201MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0201MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0201MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0211MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0211MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0211MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0211MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0212MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0212MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0212MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0212MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0213MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0213MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0213MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0213MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0214MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-0214MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50090-4392MetronidazoleMetronidazoleA-S Medication SolutionsANDACurrent
50436-0227MetronidazoleMetronidazoleUnit Dose ServicesANDACurrent
53002-2470MetronidazoleMetronidazoleRPK Pharmaceuticals, Inc.ANDACurrent
53002-2470MetronidazoleMetronidazoleRPK Pharmaceuticals, Inc.ANDACurrent
54348-740MetronidazoleMETRONIDAZOLEPharmPak, Inc.ANDACurrent
54348-740MetronidazoleMETRONIDAZOLEPharmPak, Inc.ANDACurrent
54348-745MetronidazoleMETRONIDAZOLEPharmPak, Inc.ANDACurrent
54348-745MetronidazoleMETRONIDAZOLEPharmPak, Inc.ANDACurrent
55700-298MetronidazoleMetronidazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-298MetronidazoleMetronidazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-298MetronidazoleMetronidazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
58118-0527MetronidazoleMetronidazoleClinical Solutions Wholesale, LLCANDACurrent
58118-0527MetronidazoleMetronidazoleClinical Solutions Wholesale, LLCANDACurrent
58118-0527MetronidazoleMetronidazoleClinical Solutions Wholesale, LLCANDACurrent
60760-336MetronidazoleMetronidazoleSt. Mary's Medical Park PharmacyANDACurrent
60760-336MetronidazoleMetronidazoleSt. Mary's Medical Park PharmacyANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-032METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-499METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-499METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-499METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-499METRONIDAZOLEMETRONIDAZOLEDirect_RxANDACurrent
61919-499METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
63187-827MetronidazoleMetronidazoleProficient Rx LPANDACurrent