FDA.reportPublic FDA data

Application 091616

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LITHIUM CARBONATELITHIUM CARBONATETABLET, EXTENDED RELEASE;ORAL450MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091616-001LITHIUM CARBONATELITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091616-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091616-001LITHIUM CARBONATE450MGTABLET, EXTENDED RELEASE / ORALAB2011-02-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091616-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lithium Carbonate ERLITHIUM CARBONATECoupler LLC51b503f5-211f-a9cc-e063-6294a90a98952026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091616
application number: ANDA091616
Lithium Carbonate ERLITHIUM CARBONATEREMEDYREPACK INC.bd4b07d3-ce42-440f-aec3-19f4d1c445a92026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091616
application number: ANDA091616
Lithium Carbonate ERLITHIUM CARBONATEGlenmark Pharmaceuticals Inc., USA525a9d9b-cbb1-4644-a28a-8bba96f093482026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091616
application number: ANDA091616
ndc (product): 68462-224
Lithium Carbonate ERLITHIUM CARBONATEAvKAREd8ddff4d-2b77-a8f2-e053-2a95a90a5fc02026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091616
application number: ANDA091616
ndc (product): 42291-496

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-496Lithium CarbonateLithium CarbonateAvKAREANDACurrent
63629-7903Lithium CarbonateLithium CarbonateBryant Ranch PrepackANDACurrent
63629-7903Lithium CarbonateLithium CarbonateBryant Ranch PrepackANDACurrent
68462-224Lithium CarbonateLithium CarbonateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-224Lithium CarbonateLithium CarbonateGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-224Lithium CarbonateLithium CarbonateGlenmark Pharmaceuticals Inc., USAANDACurrent