Application 077336

Type
ANDA
Sponsor
SUN PHARM INDS (IN)

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL500MGNoNo
002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL750MGNoNo

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
A077336-001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORAL2006-02-09
A077336-002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORAL2006-02-09

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 UTC2026-02A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORAL2006-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORAL2006-02-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORAL2006-02-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORAL2006-02-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077336-001METFORMIN HYDROCHLORIDE500MGTABLET, EXTENDED RELEASE / ORALAB12006-02-09782e0a99824c…
2021-12-28 21:50 UTC2021-12A077336-002METFORMIN HYDROCHLORIDE750MGTABLET, EXTENDED RELEASE / ORALAB2006-02-09782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A077336-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077336-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077336-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077336-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077336-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077336-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077336-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077336-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077336-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077336-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077336-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077336-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077336-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077336-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077336-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077336-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077336-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077336-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077336-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077336-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077336-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077336-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077336-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077336-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077336-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077336-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077336-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077336-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077336-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077336-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077336-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077336-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077336-001AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077336-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077336-001AB11782e0a99824c…
2021-12-28 21:50 UTC2021-12A077336-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077336-001AB1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077336-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077336-001AB115aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077336-002AB15aa47cf7b7d7…

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.41a8bb80-7b0b-476c-8134-5d161c3239c82026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077336
application number: ANDA077336
ndc (product): 62756-142
ndc (product): 62756-143
METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC439bb230-94d8-4522-ad79-5cce5fad965b2021-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077336
application number: ANDA077336
ndc (product): 71610-447

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7847METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
21695-828METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDERebel Distributors CorpANDACurrent
50090-1981METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-2258METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEA-S Medication SolutionsANDACurrent
51655-551Metformin HCl ERMetformin Hydrochloride Extended ReleaseNorthwind PharmaceuticalsANDACurrent
53808-0613METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
55700-320METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-320METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
62756-142METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
62756-142METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
62756-143METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
62756-143METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
63629-2883METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-2883METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch PrepackANDACurrent
67296-1527METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
67296-1527METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
67296-1527METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
68071-1927METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.ANDACurrent
70518-1606METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-1606METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-1606METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-1606METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-1606METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-1606METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-3200METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-3200METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70914-000METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEHudson Scientific LLCANDACurrent
71335-0140METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0140METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0140METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71610-441METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-447METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-447METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent
76413-156Metformin hydrochlorideMETFORMIN HYDROCHLORIDECentral Texas Community Health CentersANDACurrent
76519-1152METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDEH. J. Harkins Company Inc.ANDACurrent